BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE PERSONAL RESPONSE SYSTEM

    MDR report key: 1078240 · Received July 18, 2008

    Report

    Report Number
    1220762-2008-00001
    Event Type
    Death
    Date Received
    July 18, 2008
    Date of Event
    March 26, 2006
    Report Date
    June 20, 2008
    Product Code
    ILQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    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 PHILIPS OBTAINS ADD'L INFO, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    LEGAL FILING ALLEGED THAT A SUBSCRIBER REPORTEDLY FELL WITHOUT DEPRESSING THEIR PERSONAL HELP BUTTON. LAWSUIT ALLEGES THE NECK CORD TO THE PERSONAL HELP BUTTON BECAME CAUGHT ON A PROTRUDING VANITY CABINET, RESULTING IN SUBSCRIBER DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFELINE PERSONAL RESPONSE SYSTEM SYSTEM, COMMUNICATION, POWERED ILQ 6700

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death TAMOXIFIN| XALATAN| CELBREX| SMZ-TMP-DS| FLUNISOLIDE| NIFEDIPINE| LEVOTHYROXINE| ENALAPRIL| GLIPIZIDE/XL| ATENOLOL