BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1281072 · Received January 8, 2009

    Report

    Report Number
    1720753-2008-26581
    Event Type
    Malfunction
    Date Received
    January 8, 2009
    Date of Event
    September 22, 2008
    Report Date
    October 3, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP FOUND THE TRANSFORMER WAS NOT TAPPED RIGHT. HE RETAPPED THE TRANSFORMER FOR 116 TO 121.9 VOLTS SINCE THE VOLTAGE IN SURGERY WAS MEASURING BETWEEN 117 TO 120V. AFTER RETAPPING TRANSFORMER, THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS NOT BOOTING UP. NO PATIENT INJURY WAS REPORTED.

    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