BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1033053 · Received April 23, 2008

    Report

    Report Number
    3015876-2008-00371
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 24, 2008
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILS TO DISPLAY ECG USING EITHER PT CABLE LEADS OR THE PADDLES LEAD. THERE WAS NO REPORT OF PT USE ASSOCIATED WITH THE REPORTED EVENT.

    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