Medical device manufacturer, Philips Healthcare, has issued a field safety notice concerning HeartStart MRx Monitor/Defibrillator. The affected model numbers and serial numbers are as follows:
When used in hospital transport and pre-hospital environments, the connection between the pads/paddles therapy cable (including pads CPR therapy cable, external paddles cable, and internal paddles cable/adapter) and the MRx therapy connection port could experience high levels of stress causing accelerated wear.
Wear of the connection could prevent the device from sensing that the pads/paddles therapy cable is connected. This wear could also cause the affected product to inappropriately identify the pads therapy cable, external paddles, or internal paddles. Pads/paddles therapy cable and therapy connection port wear could pose a risk for patients and/or caregivers.
The manufacturer will arrange inspection of the affected units and install a stabilizing collar if necessary. The manufacturer advises healthcare professionals that the affected product can continue to be used prior to receiving the hardware update.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 26 February 2014