BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2041503 · Received March 24, 2011

    Report

    Report Number
    1720753-2011-02766
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 24, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RESET THE CIRCUIT BREAKER. THE SYSTEM WAS FOUND TO BE WORKING AND PUT BACK INTO SERVICE. THE CUSTOMER CANCELED THE SERVICE CALL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 9900 SYSTEM WOULD NOT TURN ON PRIOR TO A CASE. 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