Medical device safety information from UK MHRA

As per recent medical device safety information from MHRA, the Philips HeartStart MRx monitor/defibrillator therapy selector switch may fail, resulting in abnormal device behaviours including:

• the device may not perform the selected function
• the therapy knob may not change to the energy setting selected
• the device may deliver a shock with an energy level different from the setting selected by the user

If one of these behaviours occurs in clinical use, there may be a delay of therapy or a failure to deliver the intended therapy.

MHRA provided advice for healthcare professionals to read manufacturers field safety notice on given advice on how to prevent this from happening.

manufacturer’s field safety notice (FSN)

MHRA’s alert on all models of dermal filler Top-Q® (hyaluronic acid filler manufactured by Qufu Hi-Tech Trading Co Ltd) are being sold with a falsely applied CE Mark.

These devices have been manufactured to unknown standards and their safety as medical devices cannot be verified. Treatment with Top-Q® may lead to unexpected effects or complications in injected patients.

Advice for healthcare professionals:

• Do not use any Top-Q® dermal fillers and quarantine them immediately.
• Do not buy Top-Q® dermal fillers.
• Report suspected or actual adverse events involving these devices.

Reference: MHRA medical device safety bulletin