BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE PERSONAL RESPONSE SYSTEM

    MDR report key: 1085738 · Received July 31, 2008

    Report

    Report Number
    1220762-2008-00002
    Event Type
    Death
    Date Received
    July 31, 2008
    Date of Event
    July 11, 2007
    Report Date
    July 2, 2008
    Product Code
    ILQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBSCRIBER DID NOT PRESS THEIR PERSONAL HELP BUTTON DURING THE FALL. IT DOES NOT APPEAR FROM AVAILABLE INFO THERE WAS ANY MALFUNCTION OF THE DEVICE. THIS APPEARS TO BE A VERY UNFORTUNATE ACCIDENT. IN THE EVENT THAT ADD'L INFO IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    LEGAL FILING ALLEGED THAT A SUBSCRIBER REPORTEDLY, FELL IN HER WHEELCHAIR. LAWSUIT ALLEGES THAT THE NECK CORD CAUGHT ON SOMETHING, RESULTING IN SUBSCRIBER DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFELINE PERSONAL RESPONSE SYSTEM SYSTEM, COMMUNICATION, POWERED ILQ 6600

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death