BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL

    MDR report key: 2041432 · Received March 9, 2011

    Report

    Report Number
    1218950-2011-00602
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Report Date
    February 10, 2011
    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 BATTERY CHARGE LED NO LONGER GOES ON. THIS SYMPTOM MAY INDICATE A FAILURE TO POWER UP VIA AC POWER. THERE WAS NO PT INVOLVEMENT REPORTED. PHILIPS STAFF INFORMED THE CUSTOMER THAT THIS UNIT HAS BEEN OUT OF SUPPORT SINCE (B)(6) 2006 AND THAT REPLACEMENT PARTS ARE NO LONGER AVAILABLE. BASED SOLELY ON THE CUSTOMER'S REPORT, WE WILL CONSIDER THIS TO HAVE BEEN A MALFUNCTION. THE CAUSE CANNOT BE DETERMINED BECAUSE THE DEVICE WAS NOT REPAIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY CHARGE LED NO LONGER GOES ON. THIS SYMPTOM MAY INDICATE A FAILURE TO POWER UP VIA AC POWER. THERE WAS NO PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODEMASTER XL LDD, MKJ, DQA LDD PHILIPS HEALTHCARE M1723B

    Patients

    Seq Age Sex Outcome Treatment
    1