BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PADDLES

    MDR report key: 2241459 · Received August 9, 2011

    Report

    Report Number
    1218950-2011-02310
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Report Date
    July 12, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE PADDLES BUTTON BROKE AND FAILED TO DISCHARGE. THERE WAS NO REPORTED PT INVOLVEMENT. THE PADDLES WERE REPLACED TO RESOLVE THE ISSUE. THE DEFECTIVE PADDLES WERE SCRAPPED AND COULD NOT BE EVALUATED. WE WILL CONSIDER THIS A MALFUNCTION OF THE PADDLES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PADDLES BUTTON BROKE AND FAILED TO DISCHARGE. THERE WAS NO REPORTED PT INVOLVEMENT.

    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