BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL

    MDR report key: 1913483 · Received November 24, 2010

    Report

    Report Number
    1218950-2010-02383
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Report Date
    October 26, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DISCHARGE DURING TESTING. THE UNIT WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER. THE SYMPTOM COULD NOT BE DUPLICATED. THE DEVICE PASSED ALL TESTING. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION. WE CANNOT DETERMINE THE CAUSE SINCE THE SYMPTOM WAS NOT DUPLICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DISCHARGE DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODEMASTER XL LDD, MKJ, DQA LDD PHILIPS HEALTHCARE M1723A

    Patients

    Seq Age Sex Outcome Treatment
    1