BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1820069 · Received August 23, 2010

    Report

    Report Number
    1720753-2010-02701
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 14, 2010
    Report Date
    August 23, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE LINE VOLTAGE WAS ADJUSTED DURING THE SERVICE CALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9900 SYSTEM SHUT OFF WITH AN OUT PUT ERROR THEN WOULD NOT POWER 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 (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1