BEUDAMED
    FDA Adverse Event Death Summary report: N

    POSEY SAFETY VEST

    MDR report key: 511791 · Received February 10, 2004

    Report

    Report Number
    2020362-2004-00002
    Event Type
    Death
    Date Received
    February 10, 2004
    Date of Event
    December 20, 2003
    Report Date
    January 30, 2004
    Manufacturer
    POSEY COMPANY
    Product Code
    FMQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS ROUTINELY RESTRAINED IN BED BY A VEST. NO BED RAILS PRESENT. PT FELL FROM BED AND WAS STRANGLED BY THE VEST WHICH WAS TIED TO THE BED. THE INVESTIGATING POLICE DETECTIVE CONCLUDED THAT INCIDENT WAS AN ACCIDENT. INSTRUCTIONS INDICATE THAT "ALL SIDERAILS MUST BE IN THE UP POSITION WHEN USING SIDERAILS" AND "IF THEIR BODY WEIGHT BECOMES SUSPENDED OFF THE ... MATTRESS, ... SUFFOCATION COULD RESULT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY SAFETY VEST RESTRAINT FMQ POSEY COMPANY 3053L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death