BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1153625 · Received September 11, 2008

    Report

    Report Number
    1720753-2008-22271
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    May 27, 2008
    Report Date
    June 6, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP FOUND A 5 VOLT SUPPLY LOW IN GENERATOR. HE ADJUSTED THE POWER SUPPLY TO 5.2 VOLTS FROM 5.04.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT SHUT DOWN AND WOULD PRODUCE BLACK IMAGE ON FIRST SHOT. THE BUTTON WILL NOT EXPOSE THE FIRST TIME THE BUTTON IS PRESSED. RIBBON FAULT AS WELL. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1