BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 1890988 · Received October 29, 2010

    Report

    Report Number
    9680959-2010-00443
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    August 12, 2010
    Report Date
    October 26, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE DID NOT EVALUATE THE SYSTEM. A GE SERVICE ENGINEER ASSISTED THE CUSTOMER OVER THE PHONE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM WILL NOT BOOT UP SINCE A FACILITY LOSS OF POWER THE PREVIOUS DAY. 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