BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2000590 · Received February 2, 2011

    Report

    Report Number
    3015876-2011-00094
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO THEN REPLACED THE SYSTEM PCB TO USER INTERFACE PCB CABLE ASSEMBLY. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED CABLE ASSEMBLY AND FOUND THE CAUSE OF THE REPORTED FAILURE TO BE THAT LINE ONE WAS OPEN BETWEEN THE CABLE-MOUNTED PLUG CONNECTORS, DESIGNATORS P30 AND P2.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CHARGE AND SHOCK BUTTONS WERE NOT FUNCTIONAL ON THE CUSTOMER'S DEVICE, WHICH WOULDN'T HAVE ALLOWED THE DEVICE TO CHARGE OR DELIVER DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    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