BEUDAMED
    FDA Adverse Event Death Summary report: N

    VEST RESTRAINT

    MDR report key: 17140 · Received October 25, 1994

    Report

    Report Number
    MW1003788
    Event Type
    Death
    Date Received
    October 25, 1994
    Date of Event
    September 25, 1994
    Report Date
    October 24, 1994
    Manufacturer
    SKIL-CARE CORP.
    Product Code
    FMQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON ENTERING A ROOM AT 8:40 PM, A NURSING ASSISTANT FOUND A RESIDENT IN A VEST RESTRAINT APPARENTLY TRYING TO CLIMB OUT OF BED. THE RESIDENT WAS PUT BACK INTO BED. AT THIS TIME HER RESPIRATIONS WERE 16 AND BLOOD PRESSURE WAS 70/40. AT 9:00 PM, THE RESIDENT EXPIRED. NO AUTOPSY WAS PERFORMED. THE RPTR SUSPECTS THE RESIDENT'S DEATH WAS CAUSED BY THE VEST RESTRAINT COMPRESSING HER CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VEST RESTRAINT VEST RESTRAINT FMQ SKIL-CARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death