| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00738-3 |
| Product Name/Description |
Philips HeartStart MRx cardiac monitor / defibrillator, model numbers: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 (manual defibrillator)
Multiple affected units
ARTG Number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/07/2012 |
| Responsible Entity |
|
| Reason/Issue |
Some HeartStart MRx monitor/defibrillators may contain compromised electronic components and present the following behaviours:
·In automatic external defibrillator (AED) mode, the MRx may have difficulty interpreting the pads ECG waveform. The MRx may incorrectly analyse the rhythm or may fail to analyse the rhythm.
· In manual defibrillation mode, if the pads/paddles ECG signal is viewed, the user may have trouble interpreting the pads/paddles waveform and determining whether or not to deliver therapy.
· When using Q-CPR Measurement and Feedback, the feedback on ventilation rate may be inaccurate. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is replacing the affected component at customer facilities and is providing preventative/work around instructions. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |