BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODEMASTER XL

    MDR report key: 1922032 · Received December 8, 2010

    Report

    Report Number
    1218950-2010-02496
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Report Date
    November 16, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LDD
    PMA / PMN Number
    K954957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE FAILS TO CHARGE THE DEFIBRILLATION CIRCUIT FOR DEFIBRILLATION. THERE WAS NO PT INVOLVEMENT. THE LOCAL FSE RESOLVED THIS ISSUE BY REPLACING THE BATTERY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE FAILS TO CHARGE THE DEFIBRILLATION CIRCUIT FOR DEFIBRILLATION. THERE WAS NO PT INVOLVEMENT.

    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