BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1061778 · Received June 13, 2008

    Report

    Report Number
    3015876-2008-00604
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 16, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REPLACED ASSEMBLY AND DETERMINED THAT THE ROOT CAUSE FOR THE REPORTED FAILURE WAS AN ELECTRICAL SHORT THROUGH FET TRANSISTORS, DESIGNATORS Q1, Q2, Q6 AND D2. IT WAS ALSO OBSERVED THAT A FUSE, DESIGNATOR F1, WAS OPEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AC MAINS LIGHT WOULD NOT TURN ON WHEN THE DEVICE WAS PLUGGED IN. THE REPORTED SYMPTOM IS INDICATIVE OF A FAILURE TO OPERATE ON AC POWER. THERE WAS NO PT USE ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA