Health products company Philips Healthcare warned Hong Kong regulators on potential problems in its HeartStart MRx heart monitors and defibrillators, which may not hold up in a "transport environment" such as emergency medical services.
The devices may exhibit "accelerated wear" in high-stress use environments, which may cause breakdowns at the therapy connection port.
That could eventually prevent the device from sensing when its therapy paddles are connected, preventing the system from providing therapy.
"This wear also may cause the MRx to misidentify the pads therapy cable, external paddles, or internal paddles when they are connected to the therapy port," according to the warning. "which could result in a delay of therapy, incorrect energy delivered, spontaneous/unintended therapy energy discharge, shock to caregiver when delivering therapy, and/or interrupted pacing with lost capture and inability to regain cardiac recapture."
The devices in question were manufactured prior to June 2012, according to the warning.
Philips advised emergency healthcare providers to regularly inspect therapy cables and external paddles for wear after every patient use. The medical device company added that the cables and paddles should be replaced at least every 3 years.
