BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWITCHED INTERNAL PADDLES -4.5 CM

    MDR report key: 3844732 · Received March 12, 2014

    Report

    Report Number
    1218950-2014-01356
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Report Date
    February 18, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A PROBLEM DISCHARGING ENERGY VIA A SET OF INTERNAL PADDLES. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149704 SWITCHED INTERNAL PADDLES -4.5 CM LDD, MKJ, DQA LDD PHILIPS MEDICAL SYSTEMS M4743A

    Patients

    Seq Age Sex Outcome Treatment
    1