BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS LIFELINE GOSAFE WIRELESS COMMUNICATOR

    MDR report key: 5694336 · Received May 27, 2016

    Report

    Report Number
    MW5062593
    Event Type
    Malfunction
    Date Received
    May 27, 2016
    Date of Event
    May 26, 2016
    Report Date
    May 27, 2016
    Manufacturer
    PHILIPS LIFELINE
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    PHILIPS LIFELINK GOSAFE MEDICAL ALERT SYSTEM. COMMUNICATOR DOES NOT PERFORM AS DOCUMENTED (QUICK SETUP GUIDE, P/N 0940833, REV. 01) DURING SETUP. SETUP GUIDE READS "TURN ON THE HOME COMMUNICATOR USING THE SWITCH ON THE BACK." "PRESS THE FLASHING, ORANGE MESSAGE BUTTON WHEN YOU ARE READY TO CONTINUE." "PLUG THE POWER CORD INTO AN EASILY ACCESSIBLE OUTLET. CHOOSE A POWER OUTLET THAT CAN NOT BE TURNED OFF BY A WALL SWITCH. PRESS THE FLASHING, ORANGE MESSAGE BUTTON WHEN YOU ARE READY TO CONTINUE." PROBLEM: FLASHING ORANGE MESSAGE BUTTON DOES NOT COME ON AFTER TURNING COMMUNICATOR ON BUT BEFORE PLUGGING IN. WHEN COMMUNICATOR IS PLUGGED IN THE BUTTON DOES FLASH. THE VOICE GUIDANCE THAT LAUNCHES WHEN THE FLASHING BUTTON IS PRESSED (AFTER THE COMMUNICATOR IS PLUGGED IN) SAYS "NOW PLUG ME IN." CONFUSING TO ELDERLY CUSTOMERS BECAUSE MACHINE DOES NOT PERFORM AS THE SETUP GUIDE SAYS IT SHOULD. CALL TO TECHNICAL SUPPORT. AGENT SAYS THAT THE COMMUNICATOR MUST BE PLUGGED IN BEFORE THE MESSAGE BUTTON LIGHT WILL FLASH. TOLD HIM THAT THIS IS NOT WHAT THE INSTRUCTIONS SAY. HE REPLIES THAT INSTRUCTIONS ARE WRONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338698 PHILIPS LIFELINE GOSAFE WIRELESS COMMUNICATOR PHILIPS LIFELINE GOSAFE WIRELESS COMMUNICATOR ILQ PHILIPS LIFELINE 7000C

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other