BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLORENCE BED

    MDR report key: 5192387 · Received October 28, 2015

    Report

    Report Number
    3009591865-2015-00004
    Event Type
    Death
    Date Received
    October 28, 2015
    Date of Event
    August 18, 2015
    Report Date
    October 23, 2015
    Manufacturer
    UMANO MEDICAL INC
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT ONE (B)(6) PATIENT WAS FOUND UNCONSCIOUS ON THE GROUND, WITH HIS HEAD STUCK BETWEEN THE RAIL OF THE BED AND THE MATTRESS. IT WAS FURTHER REPORTED THAT THE PATIENT DIED THE FOLLOWING DAY. ACCORDING TO THE MEDICAL EXAMINER, THE PATIENT DIED OF A HEART ATTACK AND STROKE. AN EVALUATION OF THE UNIT WAS PERFORMED BY A SERVICE TECHNICIAN, AND NO DEFECT OR MALFUNCTION WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714020 FLORENCE BED HOSPITAL BED, A-C POWERED ADJUSTABLE FNL UMANO MEDICAL INC FL23SE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death