BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL+

    MDR report key: 4213233 · Received October 3, 2014

    Report

    Report Number
    1218950-2014-06020
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 11, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE CODEMASTER XL + WAS "ABNORMAL". THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619403 CODEMASTER XL+ LDD, MKJ, DQA LDD PHILIPS MEDICAL SYSTEMS M1722B

    Patients

    Seq Age Sex Outcome Treatment
    1