BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1903195 · Received November 12, 2010

    Report

    Report Number
    3015876-2010-01251
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 22, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE THERAPY PCB AND THE RECEPTACLE CONNECTOR ASSEMBLIES WERE REPLACED AND THEN PROPER DEVICE OPERATION WAS CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED ASSEMBLIES. THE CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO BE A SHORTED TRANSISTOR, DESIGNATOR Q6, ON THE THERAPY PCB ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD NOT RUN THE USER TEST. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE. UPON EVALUATION BY PHYSIO-CONTROL IT WAS OBSERVED THAT THE DEVICE HAD NO THERAPY FUNCTIONS.

    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