Ogos 2021 : FA-2021-07-001-MKE-005 ELI 280® Resting Electrocardiograph Patient Mismatch Software Update
FA-2021-07-001-MKE-005 ELI 280® Resting Electrocardiograph Patient Mismatch Software Update
Affected Medical Device : Welch Allyn® ELI 280® Resting Electrocardiograph
MDA Reference Number : MDA/FCA/2021-P128
MDA Registration Number : GB7422420-42749
Decription : Engineering performed a preliminary investigation and confirmed a software fault exists on the ELI 280 software. Under specific operator workflows, the software fault results in the following device malfunctions:1.If a user selects ECG "Patient A" from the directory, edits the ID (any change to the ID), and then edits "Patient A" ID again, "Patient A’s" demographics will be inserted into the "Patient B's" record (same issue as reported by customer)2.If a user selects an ECG from the directory, edits the ID (any change to the ID), and then selects either TRANSMIT or DELETE without leaving the Resting ECG screen, a different ECG record is deleted from the 280 or transmitted to an EMR system. (additional issue found during internal testing).
Local Establishment Contact Detail :
Kah Syuan LEE
Senior Specialist, QA/RA
ASEANNA
GF101-2, TOWER 2, WISMA AMFIRST, SS7/15, 47301 PETALING JAYA, SELANGOR
Email : [email protected]
