BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PADDLES

    MDR report key: 2945904 · Received January 7, 2013

    Report

    Report Number
    1218950-2013-00059
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Report Date
    December 17, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE PADDLES FAILED TO DISCHARGE. THERE WAS NO REPORTED PT INVOLVEMENT. THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PADDLES FAILED TO DISCHARGE. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8671 EXTERNAL PADDLES MKJ PHILIPS MEDICAL SYSTEMS M4746A

    Patients

    Seq Age Sex Outcome Treatment
    1