BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE PERSONAL RESPONSE SYSTEM

    MDR report key: 1444596 · Received August 18, 2009

    Report

    Report Number
    1220762-2009-00001
    Event Type
    Death
    Date Received
    August 18, 2009
    Date of Event
    January 18, 2009
    Report Date
    August 17, 2009
    Product Code
    ILQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT DOES NOT APPEAR FROM AVAILABLE INFORMATION THERE WAS ANY MALFUNCTION OF THE DEVICE. THIS APPEARS TO BE A VERY UNFORTUNATE ACCIDENT. IN THE EVENT THAT ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SENT. AT PRESENT, THE IDENTITY OF THE LADY REMAINS UNK, AND WE ARE UNABLE TO VERIFY IF SHE WAS INDEED A SUBSCRIBER OF OUR SERVICE AND, IF SHE DID OR DID NOT DEPRESS HER PERSONAL HELP BUTTON FOR ASSISTANCE DURING THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    A REPORT FROM A CORONER INDICATED THAT A WOMAN FELL IN HER HOME WHILE WEARING A PERSONAL HELP BUTTON NECKLACE. SHE WAS TRANSFERRED TO THE HOSPITAL WHERE SHE DIED OF HER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFELINE PERSONAL RESPONSE SYSTEM SYSTEM, COMMUNICATION, POWERED ILQ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death