BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1273878 · Received December 30, 2008

    Report

    Report Number
    1720753-2008-26410
    Event Type
    Malfunction
    Date Received
    December 30, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 29, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP INSPECTED THE SYSTEM AND ORDERED AND INSTALLED A SURGE SUPPRESSOR. HE COULD NOT DUPLICATE ANY CAUSE FOR THE POPPED CIRCUIT BREAKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CB2 ON THE WORKSTATION WAS TRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1