| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01288-1 |
| Product Name/Description |
Philips HeartStart MRx Monitor/Defibrillator
Model Number: M3535A
Serial Numbers: US00100100 to US00552845
Model Number: M3536A
Serial Numbers: US00100902 to US00552848
ARTG Number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
The MRx can be susceptible to one or both of the issues described below:-
1.) The CO2 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the MRx housing, making it inaccessible. This can occur if the user attempts to push the CO2 FilterLine fitting into the Inlet Port, instead of twisting it clockwise as described in the MRx Instructions for Use. A life threatening situation could occur if EtCO2 is unavailable and the clinician has no other reliable method for determining C02 status
including proper intubation without dislodgement.
2.) The handle can separate from the MRx housing due to breakage of mounts on the rear case. This is a drop hazard and may potentially cause bodily injury or failure to deliver therapy due to the unit becoming damaged during impact. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is initiating a correction to affected devices. A hardware upgrade will be provided free of charge for all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade.
This action has been closed out on the 26/10/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |