BEUDAMED
    FDA Adverse Event Death Summary report: N

    TECNOL ULTRA CARE

    MDR report key: 228165 · Received May 27, 1999

    Report

    Report Number
    228165
    Event Type
    Death
    Date Received
    May 27, 1999
    Date of Event
    March 19, 1999
    Report Date
    May 26, 1999
    Manufacturer
    TECNOL, INC.
    Product Code
    FMQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    87 YEAR OLD BLACK MALE ADMITTED 3/16/99 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. 3/24/99 VENTILATOR WAS DISCONTINUED AND PT EXPIRED. MEDICAL EXAMINER WAS NOTIFIED. DEVICE DID NOT PREVENT PT FROM SELF INJURY BY MAINTAINING POSITIONING IN BED.

    Devices

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

    Patients

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