BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 1844805 · Received September 23, 2010

    Report

    Report Number
    9680959-2010-00340
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 17, 2010
    Report Date
    September 23, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE 12 AMP FUSES IN THE MONITOR CART. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM WAS SHUT DOWN AND WOULD NOT POWER UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1