| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00401-1 |
| Product Name/Description |
Philips HeartStart MRx Monitor/Defibrillator
Model Numbers: M3535A, M3536A, and military bundles
Units:
M3535A (M3535ATZ)
M3536A (M3536ATZ)
M3536M, M3536MC
M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
The possibility of abnormal device behaviours has been identified in the HeartStart MRx Monitor/Defibrillator. The device may exhibit the following issues:
1. If the battery connecting pins (in the battery compartment of the HeartStart MRx Monitor/Defibrillator) become damaged or contaminated, it could result in a poor electrical connection that may cause the MRx to either (i) not power on or (ii) repetitively reboot, when used on battery power only
2. After unplugging the device from AC mains, there are two abnormal behaviours of the HeartStart MRx Monitor/Defibrillator that may occur:
a) After the user depresses the charge button, the device attempts to charge, and after approximately 20 seconds, generates the “Shock Equipment Malfunction” error message and is unable to deliver shock therapy.
b) Pacing may cease without warning. These device behaviours continue until the unit is reset.
Either problem could potentially delay monitoring or therapy. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising customers to take the following corrective actions:
Issue 1, inspect the HeartStart MRx battery compartment connections on the device. Include this step as part of a routine Operational Check to verify that the battery connector pins are clean, fully extended, not bent, and without residue; and
Issue 2, if the External Power Indicator light above the MRx display remains illuminated after the device is unplugged from AC mains power, leave the device unplugged, remove and reinsert the battery and confirm that the Indicator has turned off.
Customers are requested to refer to their recall notification letter for further important details.
This action has been closed out on 06/10/2020 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |