FRED easy Defibrillators manufactured by Schiller 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2012/042

CON172285

2012-07-11

2012-07-11

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON172285?tabName=allTabs

A false defibrillator error message, "transistor error", displays on screen and requires the device to be re-started. this problem may prevent shock delivery, which may result in failure to defibrillate and a reduced chance of survival for the patient. restarting of the defibrillator after display of a false error message may result in a delay to defibrillation. a software solution is either already available or under development, depending on the age of device. the older 1g units with serial numbers of 8 and 9 digits (manufactured from 2003 to 2006 inclusive) currently cannot be upgraded, as the software is under development. amazon medical will contact affected customers to provide further information, at a later date. for the remaining devices, the software will be deployed via a sd card for installation by users or the manufacturer.

Identify affected defibrillators; see manufacturer’s Field Safety Notice. MDA/2012/042 and MDA/2012/043 refer to this Field Safety Notice. If affected, contact Amazon Medical Ltd immediately for software upgrade deployment details. Provide Amazon Medical Ltd with up to date contact details via return of the fax back confirmation form in the FSN. Until software update is deployed, be aware of this problem which, if it occurs, can be rectified by a restart.