BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLE, OPERATING-ROOM, ELECTRICAL

    MDR report key: 14986219 · Received July 12, 2022

    Report

    Report Number
    14986219
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    June 16, 2022
    Report Date
    June 22, 2022
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS ON LITHOTOMY POSITION. STAFF MADE SURE EVERYTHING WAS TIGHT, SECURED, AND HAD NO MOVING PARTS. LATER ON THE CASE, PATIENT'S RIGHT LEG, ALONG WITH THE POSITIONER, FELL OFF OR BED. STAFF NOTICED THAT THE BRACKET HAD FALLEN OFF THE RAILING. CLINICAL STAFF ATTEMPTED TO PLACED BRACKET BACK ON BED, BUT WAS UNSUCCESSFUL. A DIFFERENT BRACKET WAS SUCCESSFULLY PLACED ONTO THE RAILING; AND WAS ABLE PLACE THE STIRRUP INTO THE NEW BRACKET. PATIENT WAS MOVED TO RECOVERY AND X-RAY TAKEN. X-RAYS LOOKED FINE, NO FRACTURES AND NOTHING WAS OUT OF THE ORDINARY. PATIENT STATED THAT SHE DID NOT HAVE ANY PAIN ANYWHERE. PATIENT WAS DISCHARGED HOME FROM POST-ANESTHESIA CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701546 TABLE, OPERATING-ROOM, ELECTRICAL GDC ALLEN MEDICAL SYSTEMS, INC. (01)0061552112779 (10)19-357

    Patients

    Seq Age Sex Outcome Treatment
    1 22630 DA Unknown