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:

• Model M3535A: US00100100 to US00541372
• Model M3536A: US00100902 to US00541375
• Model M3536J: US00209838 to US00332675
• Model M3536MC: US00500001 to US00500020

According to the manufacturer, a component of the MRx Processor Board may be susceptible to damage from electrostatic discharge. Damage to these components can disrupt electrocardiography (ECG) and pulse oximetry (SpO2) functionality leading to an inability to perform:

• Demand mode pacing
• 12 lead ECG acquisition and analysis
• ECG monitoring via leads
• Pulse oximetry (SpO2)

The presence of this condition will be displayed on the ready for use indicator as a solid Red X with periodic audio chirp.

A hardware upgrade will be provided to correct the issue. The manufacturer advises healthcare professionals that the affected product can continue to be used prior to receiving the hardware update. The manufacturer also provides instruction for the appropriate actions to be taken if the affected product displays a solid red 'X'.

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