BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PADDLES

    MDR report key: 3061624 · Received March 28, 2013

    Report

    Report Number
    1218950-2013-01092
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    March 9, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED A FAILURE TO SHOCK. THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS REPRESENTATIVE. THE REPORTED SYMPTOM WAS CONFIRMED AND ISOLATED TO THE EXTERNAL PADDLE SET. THE EXTERNAL PADDLE SET WAS REPLACED TO RESOLVE THE REPORTED SYMPTOM. THE DEVICE THEN PASSED ALL REQUIRED TESTING AND REMAINS AT THE CUSTOMER SITE. THIS WAS A MALFUNCTION OF THE EXTERNAL PADDLE SET. REPLACEMENT OF THE PADDLE SET RESOLVED THE REPORTED SYMPTOM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO SHOCK. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128937 EXTERNAL PADDLES MKJ PHILIPS MEDICAL SYSTEMS M4746A

    Patients

    Seq Age Sex Outcome Treatment
    1