BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20E DEFIBRILLATOR/MONITOR

    MDR report key: 1112526 · Received August 11, 2008

    Report

    Report Number
    3015876-2008-00907
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    April 20, 2008
    Report Date
    April 20, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO REDMOND AND EVALUATED BY THE FAILURE ANALYSIS CENTER. THE REPORTED PROBLEM WAS VERIFIED. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE DUE TO SHORTED COMPONENTS ON THE EOS POWER SUPPLY MODULE COMPONENTS Q1, Q2, Q6, D1 AND D2 WERE SHORTED. RESISTOR R4 WAS BURNED AND FUSE F1 WAS OPEN. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC POWER LIGHT IS NOT ILLUMINATED AND THE BATTERY IS NOT CHARGING. THE REPORTED PROBLEM IS INDICATIVE OF A POWER SUPPLY FAILURE, THAT WOULD RESULT IN THE DEVICE OPERATING ON BATTERY POWER ONLY. THERE WAS NO REPORT OF PT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA