BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE SWITCHLESS INTERNAL PADDLES

    MDR report key: 3982854 · Received June 13, 2014

    Report

    Report Number
    1218950-2014-03361
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 20, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    PMA / PMN Number
    K030417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS HEALTHCARE TO REPORT THAT THE CONNECTOR ON THE INTERNAL PADDLES WOULD NOT CONNECT WITH THE ADAPTER CABLE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351470 LARGE SWITCHLESS INTERNAL PADDLES LDD PHILIPS MEDICAL SYSTEMS M1742A 11-2013

    Patients

    Seq Age Sex Outcome Treatment
    1