BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1972631 · Received January 19, 2011

    Report

    Report Number
    3015876-2011-00055
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    November 16, 2010
    Report Date
    December 20, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE POWER SUPPLY ASSEMBLY WAS REPLACED AND PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD NOT POWER ON WITH AC POWER, BUT FUNCTIONED NORMALLY ON DC POWER. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE. UPON FURTHER EVAL, IT WAS DETERMINED THAT THE DEVICE WOULD ONLY CHARGE DEFIBRILLATION ENERGY FROM 2 TO 10 JOULES.

    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