BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 1000 DEFIBRILLATOR

    MDR report key: 1894215 · Received November 3, 2010

    Report

    Report Number
    3015876-2010-01211
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 4, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE ANALOG PCB ASSEMBLY WAS REMOVED FOR ADDITIONAL EVAL. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS AN IC CHIP, DESIGNATOR U53, ON THE ANALOG PCB ASSEMBLY. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    DURING REGULAR MAINTENANCE CHECK IT WAS OBSERVED THAT THE DEVICE WAS DISPLAYING THE WRENCH ICON. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE. UPON EVAL BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE HAD A REPEATING EVENT CODE AND WOULD NOT READ ANY ECG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 1000 DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA