BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2000610 · Received February 2, 2011

    Report

    Report Number
    3015876-2011-00095
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 11, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO FURTHER EVALUATED THE REMOVED THERAPY PCB ASSEMBLY AND FOUND THE CAUSE OF THE REPORTED FAILURE TO BE AN INTEGRATED CIRCUIT CHIP, DESIGNATOR U40.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE DEVICE HAD FAILED ITS USER TEST AND LOGGED A FAULT CODE. THE DEVICE WAS EVALUATED AND THE THERAPY PCB ASSEMBLY WAS REPLACED. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. AFTER FURTHER EVALUATION OF THE THERAPY PCB ASSEMBLY, IT WAS OBSERVED THAT AN "ABNORMAL ENERGY DELIVERED" MESSAGE APPEARED DURING TESTING AND THE PCB ASSEMBLY WOULD NOT DELIVER ANY DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    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