BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNAL PADDLES OPTION FOR DEFIBRILLATOR/MONITOR

    MDR report key: 3880785 · Received May 29, 2014

    Report

    Report Number
    1218950-2014-03014
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Report Date
    May 6, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS HEALTHCARE TO REPORT THAT DURING AN OPERATIVE PROCEDURE INTERNAL PADDLES FAILED TO DISCHARGE, THE CUSTOMER HAS STATED THAT THERE WAS NO IMPACT TO THE INVOLVED PT AS THEY USED A DIFFERENT DEFIBRILLATOR AND INTERNAL PADDLE SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316867 INTERNAL PADDLES OPTION FOR DEFIBRILLATOR/MONITOR MKJ PHILIPS MEDICAL SYSTEMS M4742A

    Patients

    Seq Age Sex Outcome Treatment
    1