Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-00236-1 |
Product Name/Description |
Philips HeartStart MRx Monitor/Defibrillator
Model numbers: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC
Units Affected: Serial numbers within the range US00100100 - US00550668
ARTG Number: 95661 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
27/02/2014 |
Responsible Entity |
|
Reason/Issue |
The ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which could result in an interrupted ECG signal. Interruption of the ECG signal can cause: - Loss of demand mode pacing - Inability to perform synchronized cardioversion with paddles - Disruption of leads ECG monitoring, which could delay appropriate treatment
Defibrillation, fixed mode pacing, ECG monitoring via pads/paddles and other monitoring functions are not impacted by this issue. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Philips is initiating a hardware upgrade to the affected devices. Users can continue to use the MRx prior to receiving the hardware upgrade while remaining aware of the issues identified above. If the problem occurs refer to the HeartStart MRx Instructions For Use for troubleshooting assistance. Additional workaround instructions are provided in the customer letter. |
Contact Information |
1800 251 400 - Phillips Customer Care Centre |