| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00832-1 |
| Product Name/Description |
Philips HeartStart MRx Monitor/Defibrillator with Q-CPR
AFFECTED PRODUCTS
Product: Q-CPR meter and CPR sensor used with Philips HeartStart MRx Monitor/Defibrillator with Q-CPR option.
Units Affected: All Q-CPR meter and CPR sensor, models 453564145481, 453564257691, and M4761A are affected.
ARTG: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
28/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
Adhesive Pads:
During internal review, Philips identified that the instructions on attaching the Q-CPR meter adhesive pad to the Q-CPR meter could be improved.
Patient chest injury:
Instructions did not inform the users that properly performed CPR can result in injuries to the patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips has updated the HeartStart MRx’s Instructions for Use associated with Q-CPR meter and CPR sensor via an addendum. The addendum has instructions on application of the disposable adhesive pads, which are used with the Q-CPR meter, including a diagram which illustrates proper placement and orientation of this pad. In addition, the addendum includes general information on the types of injuries, which may occur during CPR. This action has been closed-out on 24/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |