BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600EMI

    MDR report key: 1173037 · Received September 19, 2008

    Report

    Report Number
    1720753-2008-26045
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 18, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP FOUND THE BOOT PROM DISPLAY AT REAR OF WORKSTATION WAS CONSTANTLY CYCLING. HE RE-SEATED WORKSTATION PCB'S AND POWER SUPPLY CONNECTORS. THE REP MEASURED WORKSTATION +VCC AT +5.12 VDC. TESTED SYSTEM BY REBOOTING FOUR TIMES. SYSTEM NOW BOOTS NORMALLY AND IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PREPARING FOR A CASE, THE UNIT WOULD NOT BOOT, AN ALTERNATE SYSTEM WAS BROUGHT IN TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600EMI FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1