BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWITCHED INTERNAL PADDLES

    MDR report key: 1243012 · Received November 20, 2008

    Report

    Report Number
    1218950-2008-00640
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Report Date
    October 22, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THIS INTERNAL PADDLE SET WAS NOT MEETING SPECS. PHILIPS EVALUATED THE DEVICE AND CONFIRMED THAT THE INTERNAL PADDLE SET FAILED SPECS. THE CUSTOMER RECEIVED A REPLACEMENT PADDLE SET.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THIS INTERNAL PADDLE SET WAS NOT MEETING SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWITCHED INTERNAL PADDLES MKJ PHILIPS MEDICAL SYSTEMS M4742A 08/08

    Patients

    Seq Age Sex Outcome Treatment
    1