BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVACARE

    MDR report key: 3793 · Received July 8, 1992

    Report

    Report Number
    3793
    Event Type
    Death
    Date Received
    July 8, 1992
    Date of Event
    June 18, 1992
    Report Date
    June 18, 1992
    Manufacturer
    INVACARE CORPORATION
    Product Code
    HTE
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    NURSE WAS USING THE LIFT TO PLACE PATIENT ON THE COMMODE. WHEN PATIENT WAS DONE, THE LIFT WAS RAISED AND THE PATIENT WAS MOVED IN FRONT OF THE COMMODE. THE LIFT BAR POPPED AND PATIENT DROPPED TO THE FLOOR WITH BAR HITTING THE PATIENT'S HEAD. THE PATIENT COMPLAINED OF RIB PAINS BUT NO BROKEN BONES WERE NOTED. PATIENT WAS RESPONSIVE, GOOD VITAL SIGNS AND PUPILS REACTIVE. APPROXIMATELY 2 1/S HOURS LATER, THE PATIENT BEGAN VOMITING AND BECAME UNRESPONSIVE. IMMEDIATELY TRANSFERRED BY AMBULANCE. IN ROUTE, APPROXIMATELY TEN MINUTES AWAY, THE PATIENT WENT INTO FULL ARREST.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE PATIENT LIFTER HTE INVACARE CORPORATION 9002

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death