FIELD CORRECTIVE ACTION LISTING FOR MARCH 2024
The list below contains Medical Device’s Field Corrective Action for the month of March 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 |
Local Establishment Contact Detail |
|
1 |
02/03/ 2024 |
Nexcare™ Acne Patch 36 dots with expiry date issues |
3M NEXCARE ACNE PATCH |
GA63378218217 |
LIM GEOK TIAN |
|
|
2 |
05/03/2024 |
Possible shutdown of Dräger anesthesia workstation Perseus due to possible backup battery failures |
DRAEGER ANESTHESIA SYSTEM PERSEUS A500 |
GC28284243817 |
LESLIE LIEW WAI CHONG |
|
|
3 |
07/03/2024 |
Stay safe Catheter Extensions - Silicone Tubing and PCBAs |
PD TUBING SYSTEM |
GB5396719-32241 |
RAVENDRAN A/L SUPRAMANIAM |
|
|
4 |
07/03/2024 |
Therascreen® MGMT Pyro Kit LOT shows no signals |
THERASCREEN® MGMT PYRO® KIT |
IVDC1531324-160641 |
GOH THEAN LAI |
|
|
5 |
07/03/2024 |
Atellica IM -Urine Cortisol Negative Bias |
ATELLICA IM CORTISOL (COR) |
IVDB37977157518 |
FRAZER RODERICK JOHN |
|
|
6 |
07/03/2024 |
ADVIA Centaur -Urine Cortisol Negative Bias |
ADVIA CENTAUR® CORTISOL (COR) |
IVDB2211648817 |
FRAZER RODERICK JOHN |
|
|
7 |
08/03/2024 |
Trilogy Evo- Loss of Power Alarm |
TRILOGY EVO |
GC2627520-39891 |
CHAN JIN HOE |
|
|
8 |
08/03/2024 |
Trilogy EV300- Loss of Power Alarm |
TRILOGY EV300 |
GC5498920-50666 |
CHAN JIN HOE |
|
|
9 |
11/03/2024 |
Open service ports for Flow Family Anesthesia systems |
GETINGE FLOW-I ANESTHESIA SYSTEM |
GC25644700318 |
LIM WOON SUN |
|
|
10 |
11/03/2024 |
Percept™ PC Implantable Neurostimulator (INS) Model B35200 Unable to be Interrogated |
PERCEPT PC BRAINSENSE SYSTEM |
GD10703821-52185 |
YAM KIN HUNG |
|
|
12 |
12/03/2023 |
ACHC 24-02 Atellica CH HDL Cholesterol Calibrator (HDLC CAL) - Incorrect Shelf-Life and Expiration Date |
ATELLICA® CH HDL CHOLESTEROL (HDLC) |
IVDB5289622-97895 |
FRAZER RODERICK JOHN |
|
|
13 |
13/03/2024 |
UMBILICAL CORD CLAMP WITH DIFFICULTY IN CLAMPING |
UMBILICAL CORD CLAMP |
GA8595320-39514 |
LEW OON YEW |
|
|
14 |
13/03/2024 |
SOME CASES OF DETACHED ECG ELECTRODE FOAMS |
ECG ELECTRODES FOAM |
MDA/FCA/PX0700-49428044-2024 |
GA8980519-30337 |
LEW OON YEW |
|
15 |
19/03/2024 |
MR Systems: Patient support floor plate cage installation issue leading to potential for tipping |
ACHIEVA SERIES |
GB44884842218 |
CHAN JIN HOE |
|
|
16 |
19/03/2024 |
MR Systems: Patient support floor plate cage installation issue leading to potential for tipping |
INGENIA 1.5T, INGENIA 3.0T |
GB63162332517 |
CHAN JIN HOE |
|
|
17 |
19/03/2024 |
MR Systems: Patient support floor plate cage installation issue leading to potential for tipping |
INGENIA CX |
GB25631685418 |
CHAN JIN HOE |
|
|
18 |
19/03/2024 |
MR Systems: Patient support floor plate cage installation issue leading to potential for tipping |
INGENIA ELITION |
GB179941251719 |
CHAN JIN HOE |
|
|
19 |
21/03/2024 |
HeartMate 3 Inflow O Ring Seal Interface with Apical Cuff |
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM |
GD4151721-74880 |
YUMITRA A/P DHORAI RAJA |
|
|
20 |
22/03/2024 |
Artis zee / Q / Q.zen systems without a coolant level sensor |
ARTIS ZEE |
GC94505212917 |
FRAZER RODERICK JOHN |
|
|
21 |
22/03/2024 |
Artis zee / Q / Q.zen systems without a coolant level sensor |
ARTIS Q |
GC98740520118 |
FRAZER RODERICK JOHN |
|
|
22 |
25/03/2024 |
Atellica IM and Atellica CI High-Sensitivity Troponin I (TnIH) Invalid Calibration |
ATELLICA® IM HIGH-SENSITIVITY TROPONIN I (TNIH) |
IVDC82175372719 |
FRAZER RODERICK JOHN |
|
|
23 |
27/03/2024 |
Prevention of ventricular perforation and fiber ingestion for Impella heart pumps |
IMPELLA CP® WITH SMARTASSIST® SET |
MDA/FCA/P0701-80851430-2024 |
GD9474523-140294 |
VIBAGAR A/L SUKUMARAN |
|
24 |
29/03/2024 |
Informing to Stop Using UHI-4 Until Corrections Are Completed |
HIGH FLOW INSUFFLATION UNIT |
GB929511113418 |
HIDEKI NAGAI |