BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM

    MDR report key: 230849 · Received July 1, 1999

    Report

    Report Number
    1720753-1999-00002
    Event Type
    Malfunction
    Date Received
    July 1, 1999
    Date of Event
    June 1, 1999
    Report Date
    June 24, 1999
    Manufacturer
    OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON JUNE 1, 1999 OEC MEDICAL SYSTEMS, INC. WAS NOTIFIED OF AN INCIDENT THAT INVOLVED AN OEC MODEL 9600 SERIES C-ARM. THE C-ARM WAS NOT IN USE AND WAS STORED IN THE CORNER OF A ROOM, WHEN THE LASER AIMER DEVICE (AN ACCESSORY THAT IS ATTACHED TO THE IMAGE INTENSIFIER) DISENGAGED AND FELL TO THE FLOOR. THE EVENT DID NO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. HOWEVER, IF THIS MALFUNCTION WERE TO RECUR TO THIS DEVICE OR ANY OTHER MARKETED DEVICE DURING A SURGICAL PROCEDURE, IT COULD CAUSE OR CONTRIBUTE TO AN INJURY.AN OEC FIELD SERVICE ENGINEER TESTED/INSPECTED THE SYSTEM AND DETERMINED THE CAUSE OF THE MALFUNCTION WAS A LOOSE BOLT THAT SECURES THE LOCKING HANDLE OF THE LASER AIMER DEVICE. THE LASER AIMER DEVICE WAS REPLACED AN THE SYTEM IS OPERATING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUOROSCOPIC IMAGE INTENSIFIED SYSTEM MOBIL C-ARM SERIES 9600 JAA OEC MEDICAL SYSTEMS INC. 9600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other