BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PADDLES

    MDR report key: 1930486 · Received November 30, 2010

    Report

    Report Number
    1218950-2010-02409
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Report Date
    November 3, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THIS DEFIBRILLATOR PADDLE SET WAS INTERMITTENTLY FAILING. THERE WAS NO REPORT OF PT INVOLVEMENT. THE CUSTOMER ORDERED A REPLACEMENT PADDLE SET TO RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THIS DEFIBRILLATOR PADDLE SET WAS INTERMITTENTLY FAILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PADDLES MKJ PHILIPS HEALTHCARE M4746A

    Patients

    Seq Age Sex Outcome Treatment
    1