BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2941026 · Received January 31, 2013

    Report

    Report Number
    1720753-2013-01317
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 31, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFO IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGES WERE BLACK AND GRAY AND NO STRUCTURES COULD BE RECOGNIZED. THIS RENDERED THE IMAGES UNUSABLE AND CONSEQUENTLY, THE SYS WAS RENDERED UNUSABLE. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43637 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1