BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFELINE PERSONAL RESPONSE SYSTEM

    MDR report key: 2593054 · Received May 24, 2012

    Report

    Report Number
    1220762-2012-00002
    Event Type
    Injury
    Date Received
    May 24, 2012
    Date of Event
    January 9, 2012
    Report Date
    May 15, 2012
    Product Code
    ILQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT DOES NOT APPEAR FROM AVAILABLE INFO, THERE WAS ANY MALFUNCTION OF THE DEVICE. OUR RECORDS DID NOT INDICATE A HELP CALL WAS INITIATED DURING THE TIME OF THE EVENT. PER PHILIPS LIFETIME AUTOALERT HELP BUTTON. INSTRUCTIONS FOR USE, (P/N 0940718 REV. 1) P. 4 STATES: "CAUTION: IN CERTAIN SITUATIONS, THE AUTOHELP BUTTON MAY NOT DETECT A FALL. A GRADUAL SLIDE FROM A SEATED POSITION SUCH AS FROM A WHEELCHAIR-MAY NOT REGISTER AS A FALL AND WOULD NOT BE DETECTED. IF YOU FALL AND NEED HELP, ALWAYS PUSH THE HELP BUTTON IF YOU ARE ABLE TO." THE PERSONAL HELP BUTTON HAD DETECTED OTHER FALLS FROM THIS SUBSCRIBER. IN ADDITION, THE BUTTON WAS DEPRESSED AFTER THE INCIDENT AND A HELP CALL WAS SUCCESSFULLY INITIATED. IN THE EVENT, THAT ADD'L INFO IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    USER ALLEGED THAT DEVICE USER WAS FOUND ON HER SIDE ABOUT 5 FEET FROM HER RECLINER. SHE LANDED ON A HEATING GRATE WHICH HAD BENEATH IT A HOT WATER HEAT EXCHANGER THAT GENERATED 200 DEGREE TEMPERATURE. SHE LAID ON THE HEATING GATE UNCONSCIOUS FOR SEVERAL HOURS. SHE SUSTAINED BURNS ON HER ARMS AND SHOULDER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization