Welch Allyn AED 20 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2007/085

CON2032948

2007-11-07

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2032948

Failure to defibrillate. the manufacturer is recalling a specific batch of these defibrillators to correct a malfunction that prevents or delays the delivery of therapy, which can lead to failure to resuscitate a patient. this recall is in addition to a batch of aed 20 defibrillators recalled in july 2006 to correct a similar malfunction (mda/2006/047). a malfunction is caused by an intermittent connection between a pin and socket on a circuit board inside the defibrillator. the problem develops over time and is unpredictable. the aed 20 has a self-monitoring feature that detects this problem and displays a ‘defib comm’ error message. the problem is often identified while the device is being tested before use but has also occurred while practitioners are attempting to use the device on a patient. the manufacturer issued recall letters to their distributors on 29 august 2007. this is an extension of a recall covered by mda/2006/047 issued in august 2006. the manufacturer is offering loan devices whilst those affected are being upgraded free of charge.

Identify affected devices using the list of serial numbers in the appendix. Contact the manufacturer to arrange service and upgrade as soon as possible. Consider if it is appropriate to substitute alternative defibrillators for those affected devices that are in service but are awaiting upgrade. If affected devices awaiting upgrade are used and display a ‘Defib Comm’ error message, the manufacturer has advised that switching the device off and then on again may clear the error message. The equipment maintenance records should be updated when upgraded units are returned.