BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XE

    MDR report key: 3221523 · Received July 1, 2013

    Report

    Report Number
    1218950-2013-02755
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 6, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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

    CUSTOMER STATES THE PAD PROTECTORS ARE BROKEN ON THE CODEMASTER XE. IT IS NOT CLEAR IF IT IS A PADDLE OR A PADDLE TRAY SINCE PADS ARE FOR ONE TIME USE. CUSTOMER STATES NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297863 CODEMASTER XE MKJ, DQA LDD PHILIPS MEDICAL SYSTEMS M1724A

    Patients

    Seq Age Sex Outcome Treatment
    1