BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE PERSONAL RESPONSE SYSTEM

    MDR report key: 2211634 · Received August 5, 2011

    Report

    Report Number
    1220762-2011-00001
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    October 25, 2011
    Report Date
    March 22, 2011
    Product Code
    ILQ
    PMA / PMN Number
    K914013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S RECORDS ALSO INDICATES THAT THE SUBSCRIBER HAD BEEN USING THE LIFELINE DEVICE AND SERVICE FOR APPROXIMATELY 8 MONTHS PRIOR TO THE TIME THAT THE DEVICE STOPPED FUNCTIONING, AND HAD SUCCESSFULLY TESTED THE FUNCTIONALITY OF HER PERSONAL HELP BUTTON MONTHLY AS DIRECTED DURING THAT TIME. THEREFORE, DESPITE THE FAMILY'S ALLEGATION THAT THE SUBSCRIBER TRIED TO SUMMON HELP VIA THE PHB, IT IS CLEAR THAT THE SUBSCRIBER WAS AWARE THE PHB WAS NON-FUNCTIONAL. BASED ON AVAILABLE INFORMATION TODAY, IT IS CLEAR THAT THE SUBSCRIBER WAS AWARE THE PHB WAS NON-FUNCTIONAL. BASED ON AVAILABLE INFORMATION TODAY, IT IS OUR CONCLUSION THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE SUBSCRIBER OUTCOME. THE FAMILY FIRST NOTIFIED THE MANUFACTURER OF THE SUBSCRIBER DEATH IN A LETTER DATED (B)(6), 2011. BASED ON THE INFORMATION PROVIDED AND REVIEW OF OUR RECORDS THE MANUFACTURER HAD CONCLUDED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE DEATH AND WAS THEREFORE, NOT REPORTABLE. SUBSEQUENTLY HOWEVER, THE DEVICE WAS RETURNED TO THE MANUFACTURER (B)(4) 2011 AND PRELIMINARY EVALUATION WAS COMPLETED (B)(4) 2011. THIS EVALUATION CONCLUDED THAT THE BATTERY IN THE PERSONAL HELP BUTTON WAS DEPLETED. WE ARE CURRENTLY INVESTIGATING THE POSSIBLE ROOT CAUSE(S) OF THE BATTERY DEPLETION IN THIS DEVICE DETERMINE IF THIS ISSUE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WAS TO RECUR. THEREFORE, OUR "BECOME AWARE" DATE FOR A POSSIBLE MALFUNCTION OF THE DEVICE WAS (B)(4) 2011. ALTHOUGH WE DO NOT HAVE ENOUGH INFORMATION TO DETERMINE REPORTABILITY TODAY, WE ARE CONSERVATIVELY REPORTING THIS EVENT AS A POSSIBLE DEVICE MALFUNCTION. ONCE OUR INVESTIGATION HAS BEEN COMPLETED, WE WILL SUBMIT A FOLLOW UP REPORT TO FDA.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A FAMILY MEMBER THAT A LIFELINE SUBSCRIBER HAD SUFFERED A STROKE. THE FAMILY ALLEGES THAT THE SUBSCRIBER TRIED TO SUMMON HELP VIA HER LIFELINE PERSONAL HELP BUTTON (PHB) AT THE TIME OF THE STROKE, BUT IT DID NOT FUNCTION. COMMUNICATIONS FROM THE FAMILY INDICATED THAT THE SUBSCRIBER WAS AWARE THAT THE DEVICE HAD NOT BEEN WORKING PROPERLY FOR 2 MONTHS PRIOR TO THE STROKE AND HAD MENTIONED THIS TO AT LEAST ONE FAMILY MEMBER. ALTHOUGH THE FAMILY ALLEGES THAT THE SUBSCRIBER ATTEMPTED TO USE THE PHB TO SUMMON HELP, THIS CANNOT BE CONFIRMED. INSTEAD, EMERGENCY SERVICES WERE SUMMONED BY A FAMILY MEMBER. FOLLOWING THE STROKE AND ADMISSION TO THE HOSPITAL, THE SUBSCRIBER DIED IN THE HOSPITAL SIX DAYS LATER. REVIEW OF OUR RECORDS CONFIRMS THAT THE PHB WAS NON-FUNCTIONAL FOR APPROXIMATELY 2 MONTHS PRIOR TO THE INCIDENT AND THAT REPEATED COMMUNICATIONS FROM THE MANUFACTURER TO THE SUBSCRIBER, REQUESTING HER TO TEST HER PHB WERE RECEIVED, BUT LIFELINE WAS NOT CONTACTED BY THE SUBSCRIBER OR HER FAMILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFELINE PERSONAL RESPONSE SYSTEM SYSTEM, COMMUNICATION, POWERED ILQ L6800XT

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR