BEUDAMED
    FDA Adverse Event Other Summary report: N

    CADENCE PHYSIO QC ADULT RTS

    MDR report key: 2997557 · Received February 26, 2013

    Report

    Report Number
    1219103-2013-00001
    Event Type
    Other
    Date Received
    February 26, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 5, 2013
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS LUDLOW
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH DEFIBRILLATOR ELECTRODES. THE CUSTOMER STATES THAT DURING THE SYNCHRONIZED CARDIOVERSION, WHEN APPLYING 200 JOULES TO REVERT THE HEART RHYTHM, THE ELECTRODE CONCENTRATED THE ENERGY IN THE BORDERS CAUSING A 1ST DEGREE BURN TO THE PT¿S CHEST. THE PATIENT WAS TREATED TOPICALLY WITH FLAMAZINE ON THE AFFECTED AREA. THE TREATMENT WAS APPLIED BY THE NURSE AT THE ELECTROPHYSIOLOGY SERVICE UNDER MEDICAL SUPERVISION OF THE ELECTROPHYSIOLOGIST DOCTOR. THE PATIENT WAS THEN REFERRED TO THEIR FAMILY PHYSICIAN FOR FOLLOW UP. ACCORDING TO THE SUPERVISOR, THE BURNS WERE MOIST. THEY WERE NOT BLISTERING, THEY WERE RED AND WHITE IN COLOR AND A BIT PAINFUL TO TOUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81305 CADENCE PHYSIO QC ADULT RTS DEFIBRILLATION ELECTRODES MLN COVIDIEN LP, FORMERLY REGISTERED AS LUDLOW 22550R 215323

    Patients

    Seq Age Sex Outcome Treatment
    1 Other