BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PADDLES

    MDR report key: 2042969 · Received March 30, 2011

    Report

    Report Number
    1218950-2011-00842
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Report Date
    February 28, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE UNIT FAILED TO RECOGNIZED THE PADDLES. THERE WAS NO REPORT OF PT INVOLVEMENT. THE CUSTOMER WAS SHIPPED A NEW SET OF PADDLES WHICH RESOLVED THE FAILURE. THE UNIT REMAINS AT THE CUSTOMER SITE WITH THE NEW PADDLES INSTALLED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED TO RECOGNIZE THE PADDLES.

    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