BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE

    MDR report key: 8011521 · Received October 28, 2018

    Report

    Report Number
    1218058-2018-00083
    Event Type
    Injury
    Date Received
    October 28, 2018
    Report Date
    October 5, 2018
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE ELECTRODE PADS USED WERE NOT RETURNED FOR EVALUATION AS PART OF THIS INVESTIGATION. HOWEVER, THE IMAGES PROVIDED BY THE CUSTOMER INDICATED THAT THE PATIENT WAS NOT PREPPED PROPERLY BEFORE APPLYING THE ELECTRODE PADS. REVIEW OF THE DEVICE ACTIVITY LOGS SHOWED MULTIPLE ADVISORY MESSAGES THAT INDICATE THE DEVICE WAS NOT RECOGNIZING A VALID PATIENT IMPEDANCE. THIS REPORT HAS BEEN ATTRIBUTED TO POOR PATIENT PREPARATION. PLEASE REFERENCE MEDWATCH REPORT 1220908-2018-02861 FOR THE REPORT AGAINST THE DEVICE FOR THIS EVENT. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO CARDIOVERT A PATIENT (AGE & GENDER UNKNOWN), THE ELECTRODE PADS SPARKED AND ARCHED. COMPLAINANT ALLEGED AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT. COMPLAINANT ALLEGED THAT THE PATIENT SUBSEQUENTLY SUSTAINED A BURN. THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ON THE DEGREE OF THE BURN. PLEASE REFERENCE MEDWATCH REPORT 1220908-2018-02861 FOR THE SAME EVENT REPORTED FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851987 PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE DEFIB/PACING ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-4006 2618 00847946016661

    Patients

    Seq Age Sex Outcome Treatment
    1