BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFELINE PERSONAL RESPONSE SYSTEM

    MDR report key: 7429876 · Received April 13, 2018

    Report

    Report Number
    1220762-2018-00001
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    March 13, 2018
    Report Date
    March 19, 2018
    Manufacturer
    PHILIPS LIFELINE
    Product Code
    ILQ
    UDI-DI
    00884838084957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED TO FDA IN 1220762-11-15-2017-001-R, THE INVOLVED BUTTON WAS AN AFFECTED DEVICE. THE BUTTON DID NOT HAVE THE APPROPRIATE FALL PARAMETERS. IT IS UNCLEAR FROM THE INFORMATION RECEIVED BY THE MANUFACTURER IF THE BUTTON MAY HAVE CONTRIBUTED TO ANY INJURY THE SUBSCRIBER SUSTAINED. PER AUTOALERT HELP BUTTON, INSTRUCTIONS FOR USE (P/N 0940817 REV. 7 P. 10 THE AUTOALERT HELP BUTTON CAN DETECT MOST FALLS, PROVIDING AN ADDED LAYER OF PROTECTION. IF YOU THINK YOU NEED ASSISTANCE, PUSH YOUR HELP BUTTON IMMEDIATELY TO INITIATE THE HELP CALL PUSHING THE HELP BUTTON GENERATES THE HELP CALL IMMEDIATELY. RECOMMENDED USAGE: PUSH YOUR AUTOALERT HELP BUTTON ANY TIME YOU NEED HELP. IF YOU FALL AND ARE ABLE TO, YOU SHOULD STILL PUSH THE AUTOALERT HELP BUTTON TO SEND A HELP CALL RIGHT AWAY. PER AUTOALERT HELP BUTTON, INSTRUCTIONS FOR USE, P/N 0940718 REV. 5 PAGE STATES: "IN CERTAIN SITUATIONS, THE AUTOALERT MAY NOT DETECT A FALL. SOME MOVEMENTS MAY NOT REGISTER AS A FALL AND WOULD NOT BE DETECTED." THE INVOLVED BUTTON WAS STILL ABLE TO BE DEPRESSED TO SUMMON HELP.

    Description of Event or Problem · 1

    THE SUBSCRIBER HAD A FALL DOWN SEVERAL STAIRS. SHE WAS UNCONSCIOUS. SHE WAS BLEEDING FROM THE FALL AND HAD BROKEN SEVERAL BONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272841 LIFELINE PERSONAL RESPONSE SYSTEM SYSTEM, COMMUNICATION, POWERED ILQ PHILIPS LIFELINE FD100 00884838084957

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization