MHRA issues a medical device failure alert as all HeartStart MRx defibrillators might not deliver lifesaving shocks

According to our Medicines and Healthcare products Regulatory Agency (MHRA), certain defibrillators may fail to deliver controlled shocks, cardioversion, pacing or monitoring.

The HeartStart MRx defibrillators are manufactured by Philips Healthcare and it’s believed the fault lies with the batteries. The lifesaving medical devices could fail to turn on or reboot themselves repetitively, therefore hindering administrators from being able to deliver shocks. The device could also “fail to deliver a shock or undertake pacing” after it has been unplugged from AC mains.

The battery component was intended to allow for portable use of the device, but on rare occasions, it may not enough to power up the device for controlled usage.

Philips has taken urgent steps in light of identifying these faults: in February 2017, Philips Healthcare issued a Field Safety Notification for the potentially defective defibrillators for the devices to undergo corrective measures. The manufacturer believes that a pin connecting the battery to the device may easily become damaged or clogged with debris, preventing steady power flow to the defibrillator.

Updated instructions for use

Philips Healthcare will therefore provide thorough Instructions for Use (IFU) Addendum to inform users on how to look after the devices as well as to check the machines before use to ensure they won’t fail to power up properly when needed.

The instructions will include how to check the battery connection pins in case they’re damaged or clogged, and are to provide instructive advice on what to do should the pins be damaged.

All devices affected

All HeartStart MRx defibrillator units are identified as being affected by the field safety notice. This includes module numbers M3535A, M3536A as well as any sent to the military. All medical and technical staff who use or maintain the defibrillators are being provided with a copy of the field safety notice.

How concerned should we be?

There are increasing concerns that medical device manufacturers and suppliers are not doing all they can to ensure medical devices safe for use. Devices of this nature need to be tested and retested to ensure they work effectively.

In this case, intermittent power supply for a defibrillator can mean life or death in serious circumstances.

This field safety notice is certainly a cause for concern as another make of defibrillators has been identified as being prone to suddenly shutting down as well.

LifePak 1000 defibrillators made by Physio control reportedly have a similar problem with their batteries which may result in a failure to deliver lifesaving shocks to a patient.

As a medical device that is usually used to save lives, battery failure can have fatal consequences.