BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEALTH WATCH PERSONAL RESPONSE SYSTEM

    MDR report key: 1230583 · Received November 4, 2008

    Report

    Report Number
    1054748-2008-00001
    Event Type
    Death
    Date Received
    November 4, 2008
    Date of Event
    October 6, 2006
    Report Date
    November 4, 2008
    Product Code
    IQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBSCRIBER DID NOT PRESS HER PERSONAL HELP BUTTON DURING THE FALL. AVAILABLE INFORMATION INDICATES THERE WAS NO MALFUNCTION OF THE DEVICE. THIS APPEARS TO BE A VERY UNFORTUNATE ACCIDENT. THIS MANUFACTURER IS NO LONGER MANUFACTURING AND DISTRIBUTING PRODUCT.

    Description of Event or Problem · 1

    A LETTER FROM THE DEVICE USER'S/WEARER'S LAWYER STATED THE USER FELL IN HER WHEELCHAIR WITHOUT DEPRESSING HER PERSONAL HELP BUTTON. THE LETTER ALLEGES THE NECK CORD TO THE PERSONAL HELP BUTTON BECAME CAUGHT ON THE WHEELCHAIR, RESULTING IN THE WEARER'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALTH WATCH PERSONAL RESPONSE SYSTEM SYSTEM, COMMUNICATION, POWERED IQA HW6000

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death