BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL+

    MDR report key: 3924715 · Received June 25, 2014

    Report

    Report Number
    1218950-2014-03688
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 3, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE CODEMASTER XL+ COULD NOT BE USED. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369820 CODEMASTER XL+ LDD, MKJ, DQA LDD PHILIPS MEDICAL SYSTEMS M1722B

    Patients

    Seq Age Sex Outcome Treatment
    1