BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS LIFELINE 6800 XT LIFELINE COMMUNICATOR

    MDR report key: 1738133 · Received June 24, 2010

    Report

    Report Number
    MW5016501
    Event Type
    Malfunction
    Date Received
    June 24, 2010
    Date of Event
    March 24, 2010
    Report Date
    June 17, 2010
    Manufacturer
    PHILIPS LIFELINE SYSTEMS
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FIFTY NEW LIFELINE UNITS WERE PURCHASED FROM PHILIPS LIFELINE BY (B)(6) LIFELINE PROGRAM THE END OF (B)(6) 2009. WHEN I WAS CHECKING THE UNITS PRIOR TO BEING PUT IN CLIENT'S HOMES, SEVERAL OF THE UNITS WERE FOUND TO BE DEFECTIVE. WHEN SPEAKING WITH PHILIPS LIFELINE STAFF ABOUT THIS ISSUE, I WAS TOLD THEY WERE AWARE CERTAIN LIFELINE UNITS PRODUCED DURING AN SPECIFIC TIME PERIOD COULD BE AFFECTED BY A DEFECTIVE SPRING IN THE "RESET" BUTTON THAT DETERIORATES OVER TIME. WHEN THIS SPRING DETERIORATES, THE LIFELINE UNIT DOES NOT WORK. THIS OCCURS WITHOUT WARNING. WHEN I INITIALLY CHECKED THE NEW LIFELINE UNITS IN (B)(6) OF THE 50 UNITS WERE FOUND DEFECTIVE. THESE WERE RETURNED TO PHILIPS LIFELINE AND WERE REPLACED WITH NEW UNITS NOT AFFECTED BY THE DEFECTIVE SPRING. ON (B)(6), I WAS CHECKING THE REMAINING 40 UNITS THAT HAD BEEN PREVIOUSLY CHECKED IN (B)(6). OF THE 40 REMAINING UNITS, ANOTHER 6 WERE FOUND TO BE DEFECTIVE. THIS OCCURRED WHILE THE UNITS WERE SITTING ON THE SHELF IN A CLOSET, SHUT OFF AND NOT IN USE. I DID NOT CHECK ALL 40 UNITS, I ONLY CHECKED 9 OF THE 40 AND FOUND 6 OF THESE 9 UNITS DEFECTIVE. I AGAIN CALLED PHILIPS LIFELINE STAFF TO ALERT THEM THAT ANOTHER 6 UNITS WERE FOUND TO BE DEFECTIVE. THEY SUGGESTED RETURNING THESE 6 UNITS FOR REPLACEMENT. I TOLD PHILIPS LIFELINE STAFF I WAS NOT COMFORTABLE USING ANY OF THESE LIFELINE UNITS BECAUSE THESE UNITS COULD INITIALLY BE WORKING WHEN PUT IN THE CLIENT'S HOME AND THEN BECOME NONFUNCTIONAL DUE TO THE DEFECTIVE SPRING. THIS COULD JEOPARDIZE THE LIFELINE CLIENT BECAUSE THEY THINK THE LIFELINE UNIT IS WORKING WHEN IT MIGHT NOT BE. I TOLD PHILIPS LIFELINE STAFF THAT I WANTED TO RETURN THE REMAINING 40 UNITS AND HAVE THEM REPLACED WITH NEW UNITS NOT AFFECTED BY THE DEFECTIVE SPRING. THEY AGREED TO DO THIS AND 40 NEW UNITS WERE SHIPPED. PHILIPS LIFELINE DID NOT INFORM THIS LIFELINE PROGRAM ABOUT POTENTIAL DEFECTIVE EQUIPMENT UNTIL AFTER THE DEFECTIVE EQUIPMENT WAS DISCOVERED BY THE LIFELINE PROGRAM. THEY DID NOT ATTEMPT TO RESOLVE THE ISSUE WITH A PRODUCT RECALL. INSTEAD, THEY RELIED ON THIS LIFELINE PROGRAM TO IDENTIFY THE DEFECTIVE EQUIPMENT AND REPORT IT TO THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS LIFELINE 6800 XT LIFELINE COMMUNICATOR LIFELINE UNIT ILQ PHILIPS LIFELINE SYSTEMS 6800XT

    Patients

    Seq Age Sex Outcome Treatment
    1