BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE PERSONAL RESPONSE SYSTEM

    MDR report key: 7911594 · Received September 20, 2018

    Report

    Report Number
    1220762-2018-00003
    Event Type
    Death
    Date Received
    September 20, 2018
    Report Date
    September 21, 2018
    Manufacturer
    LIFELINE SYSTEMS, INC.
    Product Code
    ILQ
    UDI-DI
    00884838081383
    PMA / PMN Number
    K914103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE (AAHB AND COMMUNICATOR) WAS RETURNED TO THE MANUFACTURER ON 8/29/2018. THE AAHB MUST BE PROGRAMMED TO THE COMMUNICATOR IN ORDER TO SIGNAL THE COMMUNICATOR AND HAVE IT DIAL THE CALL CENTER. UPON EXAMINATION IT WAS DISCOVERED THE AAHB WAS NOT PROGRAMMED TO THE COMMUNICATOR; THEREFORE, NO SIGNALS FROM THE RETURNED AAHB WOULD BE ABLE TO SIGNAL THE RESPONSE CENTER. PLEASE NOTE THAT, PER THE AUTOALERT HELP BUTTON INSTRUCTIONS FOR USE, PART NUMBER 0940718 REV. 7 P. 10, "SOME MOVEMENTS MAY NOT REGISTER AS A FALL AND WOULD NOT BE DETECTED. EXAMPLES INCLUDE, BUT ARE NOT LIMITED TO: -A GRADUAL SLIDE SUCH AS FROM A SEATED POSITION -A FALL FROM A HEIGHT OF LESS THAN 20 INCHES (0.5 METERS)" P.13- IF YOU FALL AND ARE ABLE TO, YOU SHOULD STILL PUSH THE AUTOALERT HELP BUTTON TO SEND A HELP CALL RIGHT AWAY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBSCRIBER FELL OUT OF BED. SHE HIT HER HEAD. THE FAMILY REPORTED THE SUBSCRIBER PASSED AWAY AS A RESULT OF HER FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737703 LIFELINE PERSONAL RESPONSE SYSTEM SYSTEM, COMMUNICATION, POWERED (ILQ) ILQ LIFELINE SYSTEMS, INC. FD100 (AAHB) 00884838081383

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death