BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S/5 AVANCE

    MDR report key: 1062495 · Received May 30, 2008

    Report

    Report Number
    1062495
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    April 21, 2007
    Report Date
    April 23, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    WHILE PATIENT WAS ANESTHETIZED THE ANESTHESIA MACHINE DISPLAYS SHOWED AN ERROR MESSAGE THAT THE MACHINE WAS GOING TO SHUT DOWN IN 8 SECONDS. THE MESSAGE COUNTED DOWN FROM 8 AND SHUT OFF. THE ANESTHESIOLOGIST WAS ABLE TO CYCLE THE POWER AND BRING THE MACHINE BACK ON LINE.====================== MANUFACTURER RESPONSE FOR ANESTHESIA SYSTEM, S/5 AVANCE======================A GE FIELD SERVICE ENGINEER (FSE) WAS ON SITE THE SAME DAY OF THE INCIDENT TO TEST AND EVALUATE THE ANESTHESIA MACHINE. THE GE FSE REPLACED THE ON/STANDBY SWITCH AND WIRING HARNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S/5 AVANCE ANESTHESIA SYSTEM BSZ GE MEDICAL SYSTEMS, LLC S/5 AVANCE *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO NO OTHER THERAPIES| NO OTHER THERAPIES