BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-ARM

    MDR report key: 20704 · Received March 2, 1995

    Report

    Report Number
    20704
    Event Type
    Malfunction
    Date Received
    March 2, 1995
    Date of Event
    February 24, 1995
    Report Date
    March 2, 1995
    Manufacturer
    ACOMA MEDICAL IMAGING, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    PT IN OR FOR HIP PINNING UNDER GENERAL ANESTHESIA. INTRA-OPERATIVELY, SURGEON NEEDED FLUOROSCOPY X-RAYS DONE IN ORDER TO VERIFY PROCEDURE ACCURACY. APPROX 5 SECONDS INTO PROCEDURE, THE C-ARM WENT INTO ERROR MODE AND WOULD NOT RESET. AFTER 25 MINUTES, THE C-ARM BECAME OPERATIONAL AGAIN. THUS, PROLONGED ANESTHESIA TIME OF 25 MINUTES. THIS SAME SCENARIO HAD HAPPENED PREVIOUSLY. SERVICE REPS COULD NOT IDENTIFY THE PROBLEM. BOTH SERVICE REPS AND THE MFR REPS WERE CALLED IN. ACTIONS TAKEN BY THEM DID NOT ELIMINATE PROBLEM. PT'S SURGERY WAS COMPLETED. TOLERATED WELL BY THE PT WITH NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-ARM HFC-7 C-ARM FLUORO/X-RAY UNIT JAA ACOMA MEDICAL IMAGING, INC. C44-4010

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other