FIELD CORRECTIVE ACTION LISTING FOR JANUARY 2024
The list below contains Medical Device’s Field Corrective Action for the month of January 2024. This list provides field corrective action reporting information to MDA by establishment in accordance to requirement stipulated in Section 41, Act 737 and Regulation 6 of Medical Device (Duties and Obligations of Establishment) Regulations 2019.
Field Corrective Action (FCA) is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices in the Malaysia market. It is a corrective or preventive action in relation to a medical device which may include –
- The return of the medical device to the establishment;
- Modification of the medical device;
- Exchange of the medical device;
- Destruction of medical device; or
- Specific advice on the use of the medical device.
If you have experienced any safety and performance issue with one of the medical devices listed for FCA action, please seek advice from your medical device authorised representative as soon as possible.
|
No |
Date received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Description |
Local Establishment Contact Detail |
|
1 |
25 Jan 2024 |
3M SURGICAL CLIPPER BLADE ASSEMBLY - Medical Device Safety Notification |
3M SURGICAL CLIPPER WITH PIVOT HEAD |
MDA/FCA/P0652-77922719-2024 |
GA67353133017 |
This safety notification has been initiated to disclose maximum potential temperature of the clipper blades during use and the conditions for safe contact to be in compliance with the IEC 60601-1 standard and further reduce the potential for injury. |
CHUAH CHIEW TENG SENIOR EHS & REGULATORY MANAGER 3M MALAYSIA SDN BHD |
|
2 |
23 Jan 2024 |
CALIBRATION SERUM |
MDA/FCA/P0630-86304190-2023 |
IVDB241627216 |
Randox Laboratories has identified that CK Total in Calibration Serum Level 3, CAL2351 is running with a positive bias on RX Series instruments compared to other methods. We have reassigned that target values in the above lot numbers in line with both the IFCC and DGKC reference materials. |
NURAISYAH BINTI AHMAD SHUKRI REGULATORY AFFAIRS & QUALITY ASSSURANCE SPECIALIST ANDAMAN MEDICAL BRIDGE SDN. BHD. |
|
|
3 |
24 Jan 2024 |
HUMAN ASSAYED MULTI-SERA |
MDA/FCA/P0631-13390491-2023 |
IVDC53152117318 |
Randox Laboratories can confirm that there have been transcription errors on the Instruction For Use (IFU) for Human Assayed Multi-Sera Level 2, HN1530, for the lots listed in the Urgent Field Safety Notice (complaint reference REC701, Part 3). |
NURAISYAH BINTI AHMAD SHUKRI REGULATORY AFFAIRS & QUALITY ASSSURANCE SPECIALIST ANDAMAN MEDICAL BRIDGE SDN. BHD. |
|
|
4 |
1 Feb 2024 |
Possible overfilling of the humidifier due to incorrectly installed refill hose by the operator |
SOPHIE |
MDA/FCA/P0658-66644416-2024 |
GC8951523-136057 |
If the amount of water flowing down is too large, this is detected by the Sophie's level sensors and indicated by the high-priority alarm "Water level high". In extreme cases, this can cause the water to overflow into the ventilation tubes. In this situation, starting mechanical ventilation may pose an unacceptable risk to the patient. |
KHO BENG TEIK FRITZ STEPHAN SOUTHEAST ASIA SDN BHD |
|
5 |
1 Feb 2024 |
Potential hazard of device failure due to defective heater cable. |
SOPHIE |
MDA/FCA/P0666-26434884-2024 |
GC8951523-136057 |
The “measure menu” in the display of a Sophie ventilator was opened without the user input. This behaviour can be caused by an inadvertent contact of the heater cable live wire with the wire mesh shielding, in this case of a defect or an inappropriate repair of the breathing circuit heater wires or its adapter cable. |
KHO BENG TEIK FRITZ STEPHAN SOUTHEAST ASIA SDN BHD |
|
6 |
2 Jan 2024 |
CENTRICITY HIGH ACUITY CRITICAL CARE |
MDA/FCA/P0643-25003408-2024 |
GMD17215498118A |
Centricity Critical Care (CCC), Centricity Anesthesia (CA), Centricity High Acuity Anesthesia (CHA-A) and Centricity High Acuity Critical Care (CHA-CC) products do not support deleting patient allergies via interface messaging. Once a patient allergy is imported, the data will remain in the CCC, CA, or CHA system even when deleted from the external system, leading to a potential mismatch of patient allergy information between the two systems. This could lead to suboptimal treatment of patients. |
LIM SOCK SIANG DIRECTOR GE HEALTHCARE SDN. BHD |
|
|
7 |
2 Jan 2024 |
LOGIQ P SERIES (LOGIQ P8, LOGIQ P9, LOGIQ P10) |
MDA/FCA/P0644-90383262-2024 |
GB4889221-73580 |
GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes that can result in a double image artifact creating a ghost image with realistic features. An unrecognized artifact may lead to misdiagnosis. |
LIM SOCK SIANG DIRECTOR GE HEALTHCARE SDN. BHD |
|
|
8 |
30 Jan 2024 |
ASTOPAD SYSTEM |
MDA/FCA/P0662-24598313-2024 |
GB56556811018 |
COV applied parts manufactured from May 2022 to October 2023 may potentially have internal (not visible from outside) damaged electrical insulation at a few distinct locations. The root cause is an error in the manufacturing process of the heating element. The damage could lead to localized overheating. This was identified during internal investigation after a single reported adverse event in which a patient received a burn approx. 3 cm in diameter. |
DEVANDRAN KAMELA KUMARAN OPERATIONS MANAGER GEMILANG ASIA TECHNOLOGY SDN BHD |
|
|
9 |
15 December 2023 |
AZURION 5 |
MDA/FCA/P0619-77026117-2023 |
GC10785320-48186 |
If this issue occurs, the Philips Azurion system might not recover from this fault situation causing the system to not be available. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure. |
ZAM ZARINA BINTI MAT AIL QUALITY & REGULATORY MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
|
10 |
15 December 2023 |
AZURION 7 |
MDA/FCA/P0620-67529325-2023 |
GC82521235717 |
|||
|
11 |
15 December 2023 |
AZURION 7 |
MDA/FCA/P0621-79365512-2023 |
GC82521235717 |
The connection between the FlexArm and the Table may not reestablish if the detector continues to be at approximately four (4) cm from the patient when the Table restarts. This will result in a recurring connection loss between the FlexArm and the Table, during which Table movement will be unavailable. |
ZAM ZARINA BINTI MAT AIL QUALITY & REGULATORY MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
|
12 |
15 December 2023 |
PROXIDIAGNOST N90 |
MDA/FCA/P0625-42844469-2023 |
GC625521251919 |
Issue 1: Mixed Images: Philips has identified that the Radio Fluoroscopy (RF) viewer may also display a previous patient’s radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. Issue 2: Detector Access point: Philips has identified a security vulnerability specific to the Wireless Portable Detector configuration items in Philips Support Connect (PSC). |
ZAM ZARINA BINTI MAT AIL QUALITY & REGULATORY MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
|
13 |
12 Jan 2024 |
ALLURA XPER FD OR TABLE SERIES |
MDA/FCA/P0645-67536477-2024 |
GC97115121117 |
A loss of imaging functionality could result in a delay of the procedure (including termination of the procedure, should performing a cold restart not temporarily restore system functionality). |
ZAM ZARINA BINTI MAT AIL QUALITY & REGULATORY MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
|
14 |
5 Jan 2024 |
ALLURA CENTRON |
MDA/FCA/P0646-34846840-2024 |
GC67062225117 |
A loss of imaging functionality could result in a delay of the procedure (including termination of the procedure, should performing a cold restart not temporarily restore system functionality). The potential delay in treatment and/or termination of the procedure may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with some of the most critical patients |
ZAM ZARINA BINTI MAT AIL QUALITY & REGULATORY MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
|
15 |
5 Jan 2024 |
AZURION 3 |
MDA/FCA/P0647-54139757-2024 |
GC99381544218 |
A loss of imaging functionality could result in a delay of the procedure (including termination of the procedure,should perform a cold restart not temporarily restore system functionality). The potential delay in treatment and/or termination of the procedure may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with some of the most critical patients |
ZAM ZARINA BINTI MAT AIL QUALITY & REGULATORY MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
|
16 |
5 Jan 2024 |
AZURION 7 |
MDA/FCA/P0648-44882004-2024 |
GC82521235717 |
|||
|
17 |
15 Jan 2024 |
ACHIEVA SERIES |
MDA/FCA/P0653-64995794-2024 |
GB44884842218 |
If the QBC seal becomes loose during the scanning process, the risk to the patient may include one or more of the following: skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury. |
ZAM ZARINA BINTI MAT AIL QUALITY & REGULATORY MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
|
18 |
22 Jan 2024 |
ATELLICA® IM TOTAL THYROXINE (T4) |
MDA/FCA/P0659-56763739-2024 |
IVDB79506172418 |
The purpose of this communication is to inform you of an issue with the product indicated in Table 1 below and provide instructions on actions that your laboratory must take. Siemens Healthcare Diagnostics Inc. has confirmed an inability to successfully scan the master curve card (MCC) packaged with Total Thyroxine (T4) Assay Kit Lots 07485274 or 07444274 on the Atellica IM analyzer with Software Version 1.26 and below. An analyzer error message is generated and prevents customers from testing with these assay kit lots. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN. BHD. |
|
|
19 |
29 Jan 2024 |
013 FSCA AIMC 24-04 Atellica IM Erythropoietin (EPO) Negative Bias |
ATELLICA IM ERYTHROPOIETIN (EPO) |
MDA/FCA/P0661-78937518-2024 |
IVDB5198820-45185 |
Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN. BHD. |
|
20 |
1 Feb 2024 |
014 FSCA POC 24-007 - Atellica® UAS 800/Atellica 1500 Analyzer Misidentification of Sample IDs |
ATELLICA UAS 800 ANALYZER |
MDA/FCA/P0664-62786290-2024 |
IVDB43102172618 |
Siemens Healthcare Diagnostics Inc. has confirmed an issue that has the potential to misidentify samples when ALL the following specific conditions are met: • the cuvettes run out after the start of or in the middle of sample analysis, AND • the user presses the “Continue” button within 3 seconds of the button enabling to reinitiate analysis after cuvette replacement, AND • the barcode reader does not detect a barcode (either due to a non-existent or poor-quality barcode). |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN. BHD. |
|
21 |
26 Jan 2024 |
SAFETY ALERT LIFEPAK® 15 AC Power Adapter Will Not Charge Batteries of Power Device |
LIFEPAK 15 |
MDA/FCA/P0592-33505735-2023 |
GC11512940618 |
Stryker has identified an increase in the number of complaints related to the LP15 ACPA failures with the reported symptoms of “Battery Not Charging” and “Auxiliary Power Will Not Power Device or Charge Batteries”. This issue is only applicable to ACPAs used on 110V power grids. |
NURUL AIN BINTI MAT RIPING MANAGER SIXMURS MALAYSIA SDN. BHD. |
|
22 |
15 Dec 2023 |
HEMOSIL VON WILLEBRAND FACTOR ASSAY KITS |
MDA/FCA/P0624-55850331-2023 |
IVDB17919408719 |
Our investigation into reported customer complaints identified that the product was not meeting its labelled claim for Open vial stability at 2-8°C of 3 months. A new open vial stability claims of 14 days at 2-8°C was established and cleared by the FDA. |
CHAI AI LIN MANAGER STRAITS SCIENTIFIC (M) SDN BHD |