BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1972665 · Received January 20, 2011

    Report

    Report Number
    3015876-2011-00063
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE THERAPY PCB ASSEMBLY WAS REPLACED AND PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED THERAPY PCB ASSEMBLY AND FOUND THE CAUSE OF THE REPORTED FAILURE TO BE 2 SHORTED DIODES, DESIGNATORS CR43 AND CR44 WHICH CAUSED SIGNIFICANT ELECTRONIC DAMAGE TO SEVERAL OTHER COMPONENTS ON THE THERAPY PCB ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE SELF-TEST, THE CUSTOMER HEARD A LOUD NOISE FROM INSIDE THE DEVICE AND DESCRIBED A BURNING SMELL. THE DEVICE WAS THEN UNABLE TO DELIVER ENERGY. THERE WAS NO PT USED 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