BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVACARE BED AND QUARTER LENGTH SIDE RAILS HEAD ONLY

    MDR report key: 18579102 · Received January 25, 2024

    Report

    Report Number
    18579102
    Event Type
    Death
    Date Received
    January 25, 2024
    Date of Event
    September 28, 2023
    Report Date
    January 22, 2024
    Manufacturer
    INVACARE CORPORATION
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING ROUTINE ROUNDS, CNA STATES THAT SHE ENTERED RESIDENT'S ROOM AND OBSERVED RESIDENT ENTANGLED IN QUARTER LENGTH SIDE RAIL AT THE HEAD OF THE BED. CNA NOTIFIED NURSE IMMEDIATELY. NURSE RESPONDED AND OBSERVED RESIDENT UNRESPONSIVE AND ENTANGLED IN THE QUARTER LENGTH SIDE RAIL. EMS CALLED IMMEDIATELY. EMS AT FACILITY UNABLE TO REVIVE RESIDENT. CORONER NOTIFIED PER EMS. ASSISTANT CORONER AND DEPUTY CHIEF CORONER RESPONDED. CAUSE OF DEATH ASPHYXIATION. TO OUR KNOWLEDGE THE BED NOR SIDE RAILS WERE FAULTY. ALL SIDE RAILS REMOVED FROM ALL FACILITY BEDS DUE TO ENTRAPMENT RISKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190554 INVACARE BED AND QUARTER LENGTH SIDE RAILS HEAD ONLY BED, AC-POWERED ADJUSTABLE HOSPITAL FNL INVACARE CORPORATION IHCS7

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Death DRIVE MODEL NO 14030 LOW AIR LOSS MATTRESS