Important Safety Alerts

The Australian Therapeutic Goods Administration (TGA), has issued a medical device safety alert concerning its HeartStart XL (M1783A and M5526A) 12 pin Sync Cables, manufactured by Philips Medical Systems.

According to the TGA, the following problems were found during internal testing:-
If Electrical Fast Transits (EFT) noise is injected into the monitor/defibrillator via AC mains power, and the monitor/defibrillator is connected to and receiving ECG signals from an auxiliary bedside monitor with an M1783A/M5526A 12 pin Sync Cable (8/24 feet) via the monitor's ECG Out port, then:-

• Issue 1: When using a sync cable with the HeartStart MRx or HeartStart XL, EFT noise can be mistaken as an R-wave. If this occurs when performing synchronized cardioversion, there is a potential for inducing ventricular fibrillation if shocks are synchronized to EFT noise instead of the patient's actual R-wave.
• Issue 2: When using a sync cable with the HeartStart XL+, EFT noise can disable ECG monitoring, and potentially interrupt demand mode pacing, leading to a possible delay in therapy. A power cycle is required to resume ECG monitoring, however, fixed mode pacing is not impacted by this issue.

The manufacturer will contact affected customers to arrange for replacement of new sync cable.

For details, please refer to the following link:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2014-RN-01291-1

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 12 December 2014