Hong Kong Department of Health releases safety warnings for some models of medical equipment

Hong Kong Department of Health releases safety warnings for some models of medical equipment

According to the website of the Hong Kong SAR Government, the Hong Kong Department of Health received a notice from the medical instrument supplier Medtronic International Ltd (Medtronic) on the voluntary amendments to certain types of implanted cardiac defibrillators of EnTrust and Escudo. action.

The affected implantable cardiac defibrillator has a faster voltage drop than expected, or may fail to operate to its expected product life, or may not be in the "recommended replacement" and "battery exhaustion" period Provide at least three months of instrument operation between.

According to data provided by Medtronic, the affected implantable cardiac defibrillators include the following EnTrust models: D153DRG, D153VRC, D153ATG, D154VRC, D154DRG, and D154ATG; and the following Escudo models: D144DRG and D144VRC. Among them, only the EnTrust D154VRC and D154ATG models were sold in Hong Kong, and these instruments are not currently available in Hong Kong.

Medtronic has confirmed that the cause of the problem is due to a short circuit inside the battery when the battery capacity of the instrument is consumed. To date, no reports of patient death or serious injury caused by this problem have been received.

According to Medtronic, 51 patients in Hong Kong have implanted the above two products in public or private hospitals. The manufacturer is now in contact with the attending doctor of the affected patient to inform them of the problem and the recommendations for follow-up action.

A spokesperson for the Hong Kong Department of Health urged patients who have implanted the above-mentioned affected devices to seek medical advice immediately if they have questions or feel unwell.

The Department of Health has notified the Hospital Authority, private hospitals, relevant institutions and medical organizations on the above safety warnings.

The Department of Health has not received any reports of adverse reactions so far. The Department will continue to be vigilant and monitor developments.

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