BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2061380 · Received March 18, 2011

    Report

    Report Number
    3015876-2011-00258
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER ISOLATED THE CAUSE OF THE REPORTED FAILURE TO BE THE THERAPY CABLE ASSEMBLY. PHYSIO-CONTROL PROVIDED THE BIOMED TECHNICAL ASSISTANCE AND THE THERAPY CABLE PART NUMBER INFO FOR PURCHASING A REPLACEMENT.

    Description of Event or Problem · 1

    DURING A PERFORMANCE INSPECTION, IT WAS REPORTED THAT THE DEVICE DID NOT DETECT THE THERAPY CABLE CONNECTION WHILE ATTEMPTING TO DISCHARGE ENERGY. THERE WAS NO PT USE ASSOCIATED WITH THE 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