BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE PERSONAL RESPONSE SYSTEM

    MDR report key: 2577529 · Received May 10, 2012

    Report

    Report Number
    1220762-2012-00001
    Event Type
    Death
    Date Received
    May 10, 2012
    Date of Event
    October 1, 2011
    Report Date
    May 8, 2012
    Product Code
    ILQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT DOES NOT APPEAR FROM AVAILABLE INFO, THERE WAS ANY MALFUNCTION OF THE DEVICE. OUR RECORDS SHOW THAT THE SUBSCRIBER DID NOT INITIATE A HELP CALL DURING THE TIME OF THE EVENT. PER PHILIPS LIFELINE AUTOALERT HELP BUTTON, INSTRUCTIONS FOR USE, PART NUMBER 090471806, P. 4- "WARNING - THE AUTOALERT HELP BUTTON NECK CORD IS NOT DESIGNED TO BREAK AWAY. THEREFORE, IT CAN POSE A CHOKING RISK, INCLUDING THE POSSIBILITY OF SERIOUS INJURIES AND DEATH. 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." IN THE EVENT THAT ADDITIONAL INFO IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    LEGAL FILING ALLEGES THAT DEVICE USER WAS FOUND DECEASED, LYING FACE DOWN BESIDE HER BED, WITH THE DEVICE'S CORD AROUND HER NECK AND PENDANT ON THE CORD CAUGHT BETWEEN MATTRESS AND BED FRAME. (B)(4) CONCLUDED ACCIDENTAL DEATH FROM ASPHYXIA BY HANGING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death