BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PADDLES

    MDR report key: 2201047 · Received July 1, 2011

    Report

    Report Number
    1218950-2011-01904
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Report Date
    June 6, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE EXTERNAL PADDLES WOULD NOT DISCHARGE DURING TESTING. THIS WAS IN TESTING ONLY AND THERE WAS NO PT INVOLVEMENT. PHILIPS EVALUATED THE DEVICE AND THE INVOLVED PADDLE SET AND LOCALIZED THE FAILURE TO THE EXTERNAL PADDLES. THE DEVICE WAS RETURNED TO THE CUSTOMER WITH A RECOMMENDATION TO REPLACE THE INVOLVED PADDLE SET.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE EXTERNAL PADDLES WOULD NOT DISCHARGE DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PADDLES MKJ PHILIPS HEALTHCARE - ANDOVER M3542A

    Patients

    Seq Age Sex Outcome Treatment
    1