BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE PERSONAL RESPONSE SYSTEM

    MDR report key: 3229624 · Received July 1, 2013

    Report

    Report Number
    1220762-2013-00001
    Event Type
    Death
    Date Received
    July 1, 2013
    Date of Event
    February 19, 2013
    Report Date
    June 6, 2013
    Product Code
    ILQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT DOES NOT APPEAR FROM AVAILABLE INFO THERE WAS ANY MALFUNCTIONS OF THE DEVICE. OUR RECORDS DO NOT INDICATE THE SUBSCRIBER INITIATED A HELP CALL DURING THE TIME OF THE EVENT. A CAUTION HAD BEEN PROVIDED TO THE CUSTOMER VIA A MAILING DIRECTLY FROM PHILIPS LIFELINE (B)(4) IN (B)(6) 2009, ENTITLED IMPORTANT SAFETY INFO REGARDING THE WEARING METHOD OF YOUR LIFELINE PERSONAL HELP BUTTON AND EXCERPT BELOW. "CAUTION: THE PENDANT'S NECK CORD IS NOT DESIGNED TO BREAK AWAY. THEREFORE, IT CAN POSE A CHOKING RISK, INCLUDING THE POSSIBILITY OF DEATH AND SERIOUS INJURIES. THIS MAY APPLY TO WEARERS IN WHEELCHAIRS, USING WALKERS, USING BEDS WITH GUARD RAILS, OR WHO MIGHT ENCOUNTER OTHER PROTRUDING OBJECTS UPON WHICH THE CORD CAN BECOME TANGLED. WEARERS FOR WHOM THIS IS A CONCERN MAY WISH TO CONSIDER THE WRIST STYLE METHOD. IN THE EVENT THAT ADDITIONAL INFO IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORTER STATED HER MOTHER APPEARS TO HAVE STUMBLED WHILE WALKING, WITH A WALKER, FROM HER KITCHEN AREA TO HER BEDROOM. IN THE COURSE OF HER FALL, HER PENDANT PERSONAL HELP BUTTON (PHB), WITH A NON-BREAK AWAY CORD, CAUGHT ON ONE OF THE WALKER HANDLES. THE MEDICAL EXAMINER CONCLUDED THAT SHE WAS RENDERED UNCONSCIOUS AND DIED BY ASPHYXIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297600 LIFELINE PERSONAL RESPONSE SYSTEM SYSTEM, COMMUNICATION, POWERED ILQ C6804

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death