BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1041385 · Received May 12, 2008

    Report

    Report Number
    3015876-2008-00462
    Event Type
    Malfunction
    Date Received
    May 12, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 14, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL PROVIDED CUSTOMER WITH THE PART NUMBER AND PRICING FOR A NEW THERAPY CABLE. THE CUSTOMER WILL REPLACE THE THERAPY CABLE TO RESTORE PROPER DEVICE OPERATION. THE DEVICE WILL NOT BE RETURNED TO PHYSIO FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD INTERMITTENTLY NOT RECOGNIZE THE THERAPY CABLE. THERE WAS NO 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. LIFEPAK 12 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA