Medical device manufacturer, Physio-Control, has issued a medical device safety alert concerning its LIFEPAK 20e Defibrillator/Monitor [Model/Catalog numbers: 70507-XXXXXX, 99507-XXXXXX; Lot number multiple].
The manufacturer is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off.
According to the manufacturer, the failures are the result of the manufacturing process residue located beneath a component mounted on the Power Printed Circuit Board Assembly (PCBA). This has the potential to result in a failure to deliver therapy to the patient and serious injury or death. The manufacturer has not received any adverse events reported as a result of this issue.
The manufacturer will contact potential affected users to arrange for a device correction included the replacement of the Power PCBA. The Customers are requested to follow the recommended daily Operator's Checklist steps in accordance with LIFEPAK 20e defibrillator/monitor Operating Instructions – Section 7 – Maintaining the Equipment. If the users experience any of the symptoms described above, contact the manufacturer immediately to arrange servicing to your device.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 09 January 2018