BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL+

    MDR report key: 2880990 · Received November 13, 2012

    Report

    Report Number
    1218950-2012-03762
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ANGILENTTECHNOLOGIES, INC.
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND CONFIRMED THE FAILURE. THE PROBLEM WAS ISOLATED TO THE POWER SUPPLY ASSEMBLY. THE POWER SUPPLY ASSEMBLY WAS REPLACED TO RESOLVE THE ISSUE. AFTER PASSING ALL PERFORMANCE ASSURANCE TESTES THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO POWER UP. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODEMASTER XL+ LDD, MKJ, DQA LDD ANGILENTTECHNOLOGIES, INC. M1722B

    Patients

    Seq Age Sex Outcome Treatment
    1