BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PADDLES

    MDR report key: 3061409 · Received March 27, 2013

    Report

    Report Number
    1218950-2013-01070
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 7, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE FAILED TO DELIVER ENERGY VIA PADDLES DURING OP CHECK. THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FSE. THE SYMPTOM WAS DUPLICATED. THE EXTERNAL PADDLE SET WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SERVICE. PHILIPS IS CONSIDERING THIS AS A MALFUNCTION OF THE EXTERNAL PADDLE SET. THE EXTERNAL PADDLES WERE REPLACED TO RESOLVE THE SYMPTOM. NO FORMAL RESPONSE WAS REQUESTED AND NONE IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE FAILED TO DELIVER ENERGY VIA PADDLES DURING OP CHECK. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124839 EXTERNAL PADDLES MKJ PHILIPS MEDICAL SYSTEMS M4746A

    Patients

    Seq Age Sex Outcome Treatment
    1