BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL+

    MDR report key: 3881697 · Received May 21, 2014

    Report

    Report Number
    1218950-2014-02888
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Report Date
    April 30, 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 FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS TO REPORT THAT "AT THE MOMENT OF THE CHARGE, IT PRE DISCHARGES AND NOISES ARE HEARD." THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303483 CODEMASTER XL+ LDD, MKJ, DQA LDD PHILIPS MEDICAL SYSTEMS M1722B

    Patients

    Seq Age Sex Outcome Treatment
    1