BEUDAMED
    FDA Adverse Event Death Summary report: N

    BODY ALARM

    MDR report key: 165641 · Received April 29, 1998

    Report

    Report Number
    165641
    Event Type
    Death
    Date Received
    April 29, 1998
    Date of Event
    April 4, 1998
    Report Date
    April 27, 1998
    Manufacturer
    DAC TECHNOLOGIES OF AMERICA, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RESIDENT FOUND WITH LOWER EXTREMITES ON FLOOR BY BED WITH HEAD BY MATTRESS AND 1/2 SIDE RAIL. NIGHT GOWN WAS AROUND NECK WITH BODY ALARM CORD AND CLIP ATTACHED TO NECKLINE OF NIGHT GOWN. BODY ALARM HAD BEEN ACTIVATED AND PIN OUT OF BODY ALARM BUT METAL RING ATTACHED TO PIN LODGED ON EYE BOLT ON HEADBOARD. RESIDENT PRONOUNCED DEAD AT THE SCENE. STATE BOARD OF HEALTH NOTIFIED DAC TECHNOLOGIES OF INCIDENT 4/6/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BODY ALARM PATIENT ALERT & PERSONAL ALARM KMI DAC TECHNOLOGIES OF AMERICA, INC. HCA001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Death