| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00900-1 |
| Product Name/Description |
Philips Sync Cables and Philips ECG Out Cables
Philips Sync Cables
Model Numbers: M1783A and M5526A
ECG Out Cables
Model Number: 989803195641
ARTG Number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Philips originally advised of electrical interference via Sync cables (TGA ref: RC-2014-RN-01291-1), where affected cables were replaced.
Philips is now advising users to cease using and dispose of Sync cables and ECG Out cables, as when using a sync cable or ECG out cable with the HeartStart MRx or HeartStart XL, EFT noise may be mistaken as an R-wave. If this occurs when performing synchronised cardioversion, there is a potential for inducing ventricular fibrillation if shocks are synchronised to EFT noise instead of the R-wave of the patient’s actual ECG. |
| Recall Action |
Recall |
| Recall Action Instructions |
Philips is requesting users read the supplied notice and then:
1. Remove affected sync cables and ECG out cables from service and destroy them, documenting such action on the acknowledgement form, which should be returned to Philips;
2. There are 3 options for the user to synchronise the MRx or XL+ monitor/defibrillators, so the synchronisation function is not lost. In summary, these methods are:
-The shock pads ECG can be used for synchronisation.
-If the user places or replaced 3 leads ECG pads, the resulting ECG can be used for synchronisation.
-The ECG trunk cable can be disconnected from the Philips bedside monitor and connected to the monitor/defibrillator before delivering therapy.
For further information, the customer should refer to the Instructions for Use that describe the recommended approach for performing cardioversion.
This action has been closed out on the 25/09/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |