BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRA CARE VEST STYLE BODY HOLDER

    MDR report key: 231225 · Received June 25, 1999

    Report

    Report Number
    9616096-1999-00003
    Event Type
    Death
    Date Received
    June 25, 1999
    Date of Event
    March 19, 1999
    Report Date
    May 26, 1999
    Manufacturer
    TECNOL, INC.
    Product Code
    FMQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    87 YR OLD BLACK MALE ADM TO FACILITY 03/16/99 WITH MULTIPLE MEDICAL AND SOCIAL PROBLEMS. PT WAS FOUND IN HIS ROOM IN A SAFETY VEST, SUSPENDED FROM THE SIDE OF THE BED. THE PT WAS ASSESSED BY THE NURSE AND DID NOT HAVE A PULSE AND WAS NOT BREATHING. VEST WAS UNTIED FROM FAR SIDE OF BED AND PT WAS LOWERED TO THE FLOOR. HE WAS REASSESSED FOR RESPIRATION AND A CODE BLUE WAS CALLED. THE PT WAS TRANSFERRED TO ICU AND PLACED ON A VENTILATOR. 03/24/1999 THE VENTILATOR WAS DISCONTINUED AND THE PT EXPIRED. MEDICAL EXAMINER WAS NOTIFIED. DEVICE DID NOT PREVENT THE PT FROM SELF INJURY BY MAINTAINING POSITIONING IN BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA CARE VEST STYLE BODY HOLDER PROTECTIVE RESTRAINT FMQ TECNOL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death| O HILL ROM BED