Important Safety Alerts

The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom has posted a medical device safety alert concerning the battery pack for MEDUCORE Easy, manufactured by WEINMANN Emergency Medical Technology [Model: WM 40155; Serial number: below 20000].

The manufacturer has found that in very rare cases, the battery pack may fail. In the fault situation, it would no longer be possible to administer a shock to the patient.

According to the manufacturer, the rechargeable battery pack for MEDUCORE Easy (WM 40150) is not affected and can continue to be used without restriction.

The users are advised to take the following actions:

• Replace battery packs with serial numbers below 20000 with a new battery pack;
• Ensure that they carry an alternative replacement device when on professional duty (emergency service) until they receive a replacement battery pack; and
• If the device displays the fault described above when they are on duty, continue first-aid measures in line with ERC Guideline 2015

Product replacement is on-going.

For details, please refer to the MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notices-13-february-17-february-2017

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 21 February 2017