BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2000591 · Received February 2, 2011

    Report

    Report Number
    3015876-2011-00100
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE, PHYSIO REPLACED THE THERAPY PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED THERAPY PCB ASSEMBLY AT THE FAILURE ANALYSIS CENTER; HOWEVER, THE REPORTED FAILURE WAS NOT DUPLICATED. FURTHER CONCLUSIVE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE FAILED A USER TEST. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE. UPON EVALUATION BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE WOULD NOT DELIVER DEFIBRILLATION THERAPY.

    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