BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER 100

    MDR report key: 2123603 · Received June 10, 2011

    Report

    Report Number
    1218950-2011-01649
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Report Date
    May 17, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LDD
    PMA / PMN Number
    K950483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A BATTERY DEPLETION WHILE IN USE ON A PATIENT. THIS MOST LIKELY CAUSED AN UNEXPECTED SHUTDOWN OF THE DEVICE. THERE WAS NO REPORT OF PATIENT IMPACT. PHILIPS INFORMED THE CUSTOMER THAT THIS UNIT HAS BEEN OUT OF SUPPORT SINCE (B)(6) 2006 AND THAT REPLACEMENT PARTS ARE NO LONGER AVAILABLE. NO PARTS WERE SUPPLIED TO THE CUSTOMER FOR THIS REASON. WE ARE CONSIDERING THIS A MALFUNCTION. WE CANNOT DETERMINED THE CAUSE SINCE THE DEVICE IS OUT OF SUPPORT AND CANNOT BE REPAIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BATTERY DEPLETION WHILE IN USE ON A PATIENT. THIS MOST LIKELY CAUSED AN UNEXPECTED SHUTDOWN OF THE DEVICE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODEMASTER 100 LDD, DRO LDD PHILIPS HEALTHCARE M2475B

    Patients

    Seq Age Sex Outcome Treatment
    1