BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3050803 · Received April 10, 2013

    Report

    Report Number
    3015876-2013-00287
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL HAS RECEIVED THE DEVICE FOR ANALYSIS/REPAIR AND CONTINUES TO INVESTIGATE THE REPORTED FAILURE. PHYSIO WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE USER INTERFACE AND SYSTEM CONTROLLER PCB ASSEMBLIES AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.PHYSIO FURTHER EVALUATED THE REMOVED PCB ASSEMBLIES AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A THERMALLY SENSITIVE INTEGRATED CIRCUIT CHIP, DESIGNATOR U61 FROM THE SYSTEM CONTROLLER PCB ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE INITIALLY BOOTS UP NORMALLY BUT THEN BEGINS TO CONTINUOUSLY RESTART WITH THE SELF-TEST IN PROGRESS SCREEN AFTER A MINUTE. THE DEVICE WOULD NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY IN THE REPORTED CONDITION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149800 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1