BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFELINE PERSONAL RESPONSE SYSTEM

    MDR report key: 3534177 · Received December 18, 2013

    Report

    Report Number
    1220762-2013-00002
    Event Type
    Other
    Date Received
    December 18, 2013
    Date of Event
    November 15, 2013
    Report Date
    November 18, 2013
    Product Code
    ILQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBSCRIBER'S INJURY WAS A RESULT OF A FALL DOWN A STAIR WELL. THE INVOLVED EQUIPMENT (MODEL FD100) WAS NOT THE CAUSE OF THE FALL. THE FD100 IS NOT LABELED AS A LIFE SUSTAINING DEVICE. THE INVOLVED EQUIPMENT WAS RETURNED FOR EVAL AND IT WAS DETERMINED THAT THE BATTERY ON THE SUBSCRIBER'S FD100 WAS DEPLETED. THE FD100 HAS A LOW BATTERY DETECTION ALGORITHM WHICH IS A TIME-BASED SERIES OF INTERNAL VOLTAGE CHECKS WHICH TAKES 24 HRS TO COMPLETE. IN THIS CASE, THE BATTERY DEPLETION WAS TOO RAPID WHICH RESULTED IN DEPLETION BEFORE THE FD100 ALGORITHM COULD COMPLETE ITS INTERNAL VOLTAGE CHECKS. CONSEQUENTLY, NO LOW BATTERY SIGNAL WAS SENT TO THE RESPONSE CENTER TO TRIGGER THE FD100 REPLACEMENT PROCESS. SUBSCRIBERS ARE ALSO AUTOMATICALLY REMINDED TO TEST THEIR EQUIPMENT EVERY MONTH TO DETECT ANY ISSUES.

    Description of Event or Problem · 1

    SUBSCRIBER HAD FALLEN IN THE STAIR WELL AND HIS AUTOALERT HELP BUTTON DID NOT SIGNAL. HE WAS FOUND THE NEXT DAY BY A HOME SUPPORT WORKER. IT WAS INDICATED THAT THE SUBSCRIBER HAD A BROKEN HIP AND WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663360 LIFELINE PERSONAL RESPONSE SYSTEM SYSTEM, COMMUNICATION, POWERED ILQ FD100

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization