BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFELINE PERSONAL RESPONSE SYSTEM

    MDR report key: 7141811 · Received December 22, 2017

    Report

    Report Number
    1220762-2017-00001
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    October 2, 2017
    Report Date
    December 20, 2017
    Manufacturer
    LIFELINE SYSTEMS, INC.
    Product Code
    ILQ
    UDI-DI
    00884838084957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 0940718 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. P. 13 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 BUTTON TO SEND A HELP CALL RIGHT AWAY. PER AUTOALERT HELP BUTTON, INSTRUCTIONS FOR USE, P/N 0940718 REV. 7 P. 5 STATES: "IN CERTAIN SITUATIONS, THE AUTOALERT HELP BUTTON MAY NOT DETECT A FALL.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; LOWERING ONESELF SLOWLY TO THE GROUND (TO BRACE THE IMPACT OF A FALL) , A FALL FROM A HEIGHT OF LESS THAN 20 INCHES (0.5 METERS)." THE INVOLVED BUTTON WAS STILL ABLE TO BE DEPRESSED TO SUMMON HELP.

    Description of Event or Problem · 1

    THE SUBSCRIBER FELL AND HIT HER HEAD. IT IS UNCLEAR IF SHE HIT HER HEAD AND THEN HAD A STROKE OR IF THE STROKE CAUSED HER TO FALL AND SHE HIT HER HEAD IN THE PROCESS. THIS HAPPENED IN HER BEDROOM THE NIGHT OF THE (B)(6) OR THE MORNING OF THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920713 LIFELINE PERSONAL RESPONSE SYSTEM SYSTEM, COMMUNICATION, POWERED ILQ LIFELINE SYSTEMS, INC. FD100 00884838084957

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization