BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT/CHILD REDUCED ENERGY DEFIBRILLATION ELECTRODES

    MDR report key: 2851349 · Received November 29, 2012

    Report

    Report Number
    3015876-2012-00862
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MLN
    PMA / PMN Number
    K960329
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED ISSUE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL DID NOT RECEIVE THE FAILED ELECTRODES FOR EVALUATION/ANALYSIS AS ANTICIPATED. HENCE, A CONCLUSIVE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER OPENED A SET OF ELECTRODES A WEEK OR TWO BEFORE THE EXPIRATION DATE AND OBSERVED ALL THE GLUE PEELED OFF FROM THE PAD. THE CUSTOMER OPENED AND CHECKED SEVERAL ADDITIONAL ELECTRODES AND FOUND MOST OF THEM HAD EITHER SOME OR ALL OF THE GEL FAIL TO SEPARATE FROM THE LINER. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT/CHILD REDUCED ENERGY DEFIBRILLATION ELECTRODES ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION MLN PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1