BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1964748 · Received December 23, 2010

    Report

    Report Number
    3015876-2010-01422
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    September 18, 2010
    Report Date
    November 30, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K973486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY OR DUPLICATE THE REPORTED FAILURE. PHYSIO OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. A CONCLUSIVE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT RECOGNIZE THE DEFIBRILLATOR ELECTRODES (3RD PARTY ZOLL BRAND) CONNECTION VIA THE THERAPY CABLE TO A PT TO DISPLAY THE ECG RHYTHM. THE DEVICE DEFAULT SETTINGS FOR ECG WAS LEAD II, ECG THRU THE ECG CABLE AS OPPOSED TO THERAPY CABLE, UPON POWER ON. THE USER REPORTED THAT THEY ATTEMPTED TO SELECT THE PADDLES LEAD USING THE LEAD SELECT BUTTON WITHOUT ANY SUCCESS. OTHER PARAMEDICS ARRIVED WITH A ZOLL DEVICE AND WERE ABLE TO VIEW THE PT ECG AND PROVIDE DEFIBRILLATION THERAPY. THERE WAS APPROX TWO MINUTES DELAY IN TREATMENT. THE EVENTUAL PT OUTCOME IS UNK AND THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PT PROVIDED. PHYSIO-CONTROL'S CLINICAL REVIEW OF THE REPORTED EVENT DETERMINED THAT THERE WAS INSUFFICIENT DATA AVAILABLE TO DETERMINE THE IMPACT OF THE DEVICE ISSUE.

    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 UNK