BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1001112 · Received February 14, 2008

    Report

    Report Number
    3015876-2008-00052
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    January 11, 2008
    Report Date
    January 22, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED PROPER OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. PHYSIO REPLACED THE STANDARD PADDLES TO ADDRESS WHAT WAS DESCRIBED AS DIFFICULT TO CONNECT TO THE DEVICE. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    FOUND DURING TESTING. ACCORDING TO THE REPORTER, THE DEFIBRILLATOR WAS OUTPUTTING INCONSISTENT ENERGY TO A DEFIBRILLATION TESTER. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA