BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL+

    MDR report key: 2031747 · Received March 21, 2011

    Report

    Report Number
    1218950-2011-00765
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Report Date
    February 25, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT UNIT IS NOT HOLDING CHARGE. PHILIPS TECHNICAL SUPPORT TROUBLESHOOT THE CUSTOMER'S REPORTED PROBLEM (CHARGE WILL GO TO ZERO WHEN SELECTED A LOWER VALUE SELECTED) AND STATED THAT IT COULD POSSIBLY BE THE SELECTOR KNOB ISSUE AND HIGH VOLTAGE BOARD. THE CUSTOMER WAS INFORMED THAT THIS DEVICE HAS BEEN OUT OF SUPPORT SINCE (B)(6) 2006 AND PARTS ARE NO LONGER AVAILABLE. BASED ON THE CUSTOMER'S REPORTED PROBLEM, WE WILL CONSIDER THIS A REPORTABLE MALFUNCTION OF THE UNIT. WE CANNOT DETERMINE THE CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT UNIT IS NOT HOLDING CHARGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1