BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3190287 · Received June 26, 2013

    Report

    Report Number
    3015876-2013-00552
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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 AND THEN RETURNED THE DEVICE TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE EXHIBITED A COMPLETELY WHITE SCREEN UPON BOOT UP. THE CUSTOMER ADVISED THAT THIS APPEARS TO BE AN INTERMITTENT ISSUE. THE DEVICE DOES HAVE ITS SERVICE INDICATOR ILLUMINATED NOW AND HAS LOGGED AN EVENT CODE. THE WHITE SCREEN ON THIS DEVICE INDICATES A DEVICE LOCK-UP, WHICH WOULD PROHIBIT THE DEVICE FROM DELIVERING DEFIBRILLATION ENERGY, IF NEEDED.THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289591 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1