| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00196-1 |
| Product Name/Description |
Philips HeartStart MRx Monitor/Defibrillator with Q-CPR
Units Affected: MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587
ARTG Number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
When the HeartStart MRx is in AED mode, the Q-CPR meter is designed to display the ‘Do Not Touch the Patient’ icon during the shock advisory analysis period. If the user continues to deliver chest compressions when the shock advisory analysis begins, the ‘Do Not Touch the Patient’ icon may incorrectly remain on the screen after analysis or shock delivery is complete.
When the HeartStart MRx is in Manual Mode, the Q-CPR meter is designed to display the ‘Do Not Touch the Patient’ icon when the device is charging to the selected energy. If the clinician continues to provide chest compressions while the device is charging, the Q-CPR meter ‘Do Not Touch the Patient” icon may incorrectly remain on the screen after shock delivery is complete.
Due to incorrect CPR instructions, the clinician may follow the 'Do Not Touch the Patient command on the Q-CPR Meter and may not resume chest compressions in a timely manner resulting in a delay in the delivery of CPR. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A software upgrade will be provided to customers with affected devices. Customers are advised to use their HeartStart MRx without the Q-CPR meter attached. If customers choose to use the HeartStart MRx with the Q-CPR meter attached and they observe that the Q-CPR meter is displaying the 'Do Not Touch The Patient' icon at an unexpected time, follow the MRx Instructions For Use and remove the meter from the patient and continue CPR according to their organisation's protocol.
This action has been closed out on 22/10/2018 |
| Contact Information |
1800 251 400 - Phillips Customer Care Centre |