BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES

    MDR report key: 4875390 · Received June 24, 2015

    Report

    Report Number
    1218058-2015-00031
    Event Type
    Malfunction
    Date Received
    June 24, 2015
    Date of Event
    May 30, 2015
    Report Date
    June 3, 2015
    Manufacturer
    BIO-DETEK, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT ELECTRODES WERE RETURNED TO ZOLL MEDICAL CORP. THE ELECTRODES PASSED ELECTRICAL TESTING AND WERE FOUND WITHIN SPECIFICATION. EVIDENCE OF ARCING WAS OBSERVED ON THE APEX PAD, CONSISTENT WITH THE CUSTOMER'S REPORT OF APPLYING THE PADS OVER THE PT'S DRESSING. OUR EVAL HAS CONCLUDED THAT THE REPORTED EVENT WAS CAUSED BY INSUFFICIENT COUPLING OF THE ELECTRODES. THIS COMPLAINT HAS BEEN CLOSED AS USER MISHANDLING. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE CARDIOVERTING A FEMALE PT (AGE UNK), AN ARC WAS SEEN FROM THE ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN PLACED THE ELECTRODES OVER A DRESSING THAT HAD STAPLES UNDERNEATH. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408846 ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES ELECTRODE MKJ BIO-DETEK, INC. 8900-0224-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK