BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATER RESISTANT EXTERNAL PADDLES

    MDR report key: 3060615 · Received March 27, 2013

    Report

    Report Number
    1218950-2013-01008
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    February 25, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE EXTERNAL PADDLES WERE NOT WORKING. THERE WAS NO REPORTED ADVERSE PT IMPACT. THIS COMPLAINT IS STILL BEING INVESTIGATED A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE EXTERNAL PADDLES WERE NOT WORKING. THERE WAS NO REPORTED ADVERSE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124816 WATER RESISTANT EXTERNAL PADDLES MKJ PHILIPS MEDICAL SYSTEMS M3543A

    Patients

    Seq Age Sex Outcome Treatment
    1