BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2243672 · Received August 24, 2011

    Report

    Report Number
    1720753-2011-21325
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 24, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE EVALUATION. THE SYSTEM WAS RESTARTED AND THE CUSTOMER CONFIRMED THAT THE SYSTEM WAS WORKING AS INTENDED AND PUT BACK IN SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM COULD NOT PASS THE SELF CHECK AT START UP. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1