| TGA Action ID |
RC-2025-RN-00370-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Unified Arrhythmia Diagnostic System PocketECG IV
Type: P4TR-CA-ADS, P4TR-CE-ADS, P4TR-AB-ADS
Software: PocketECG PC Client, version 9.90
Serial number: TR4923-01784A
FSCA-identifier date: 2025-01
GMDN: 31733
GMDN term: Telemetry system, electrocardiograph |
| ARTG Number |
223996 |
| Action Type |
Product Correction / Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Medicalgorithmics S.A. received one report where the device, designed for online operation, failed to transmit ECG data during two consecutive tests. The operator failed to report or investigate the transmission failure. This lead to an inaccurate diagnosis resulting in an unnecessary pacemaker implant, and serious deterioration of health of the other patient.
Investigation identified the causes for the malfunction preventing data transmission:
- a damaged SIM card slot disrupting mobile connectivity; and
- an expired software security certificate
This was an isolated incident specific to that particular unit, not related to a serial error or systemic fault in the product’s construction. Devices that fail to send ECG data should be reported to Medicalgorithmics and returned for diagnostics and repair. |
| Instructions for Customers/Users |
Medicalgorithmics is adding an additional warning in the IFU.
Customers are to:
- regularly inspect PocketECG IV devices and accessories before each use, follow the official inspection instructions provided by Medicalgorithmics.
- immediately contact Medicalgorithmics if any malfunction is detected, report the issue via the ticketing system and send in the device for repair.
- ensure automatic ECG-to-patient data linking is online. If wireless transmission fails, the device continues recording data to the SD card, preventing loss. In such cases, the data must be manually uploaded by Medicalgorithmics. Following a manual upload, the operator must verify that the ECG data correctly matches patient information in the PC Client.
This action has been finalised on 22/05/2025. |
| Action Commencement Date |
7/04/2025 |
| Responsible Entity |
|
| Contact Information |
08 7905 4722 - MDG Australia Pty Ltd |