BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3873786 · Received June 16, 2014

    Report

    Report Number
    3015876-2014-00653
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 18, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE REMOVED USER INTERFACE PCB AND SYSTEM PCB ASSEMBLIES AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO AN ELECTRICALLY LEAKY INTEGRATED CIRCUIT (IC) CHIP, DESIGNATOR U61 ON THE SYSTEM PCB ASSEMBLY. THIS INTEGRATED CIRCUIT (IC) CHIP, DESIGNATOR U61 BEING ELECTRICALLY LEAKY, CAUSED THE DEVICE TO ABORT ITS USER TEST.NO FAILURES WERE OBSERVED ON THE USER INTERFACE PCB ASSEMBLY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DISTRIBUTOR EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE DISTRIBUTOR REPLACED THE USER INTERFACE PCB AND SYSTEM PCB ASSEMBLIES. PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. FOLLOWING REPAIR, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHYSIO-CONTROL THAT THE CUSTOMER'S DEVICE WOULD NOT COMPLETE ITS SELF-TEST. THE DEVICE'S DISPLAY WAS EITHER DISTORTED OR COMPLETELY BLANK. THERE WAS NO REPORT OF ANY PATIENT USE BEING ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353383 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1