Medical device manufacturer, Medtronic Limited, has issued a medical device safety alert concerning its Single Chamber Temporary External Pacemaker 53401 [Serial numbers lower than MDB05000; Distributed between February 2017 and November 2017].
The manufacturer advises users of the potential that a subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from programmed settings to nominal settings during use with a patient due to an unexpected Power on Reset (POR). The initial version of 53401 EPG firmware was configured to allow an unused, unterminated digital input/output pin to be an input. During investigation of the issue, the unterminated pin was found to act as an antenna, which could detect external electrical signals.
According to the manufacturer, the 53401 EPG microprocessor expects the unterminated pin to be silent. When the unterminated pin detects electrical signals, device firmware may lock up and cause a POR. When the EPG experiences a POR, by design, the device will cease functioning for approximately 7 seconds while it reboots, then resume functioning at nominal settings. Through 21 May 2018, there have been 17 confirmed reports of this issue. No patient deaths or complications have been reported as a result of this issue.
The manufacturer has received approval for a firmware correction that prevents occurrence of the issue.
The affected users are recommended to send affected devices to the manufacturer's service to update the firmware to prevent the issue. Patients being treated with affected 53401 EPGs should be continuously monitored per labeled instructions for use.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 June 2018