BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODES, STAT PADZ

    MDR report key: 7191185 · Received January 15, 2018

    Report

    Report Number
    1218058-2018-00004
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Date of Event
    December 12, 2017
    Report Date
    December 26, 2017
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    10847946016453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE ELECTRODE PADS WERE RETURNED TO ZOLL MEDICAL CORPORATION; THE GEL WAS OBSERVED TO BE ATTACHED TO THE STYRENE. VISUAL INSPECTION SHOWED THE FRONT/APEX PAD WAS INSIDE THE PACKAGE AND FOLDED ONTO ITSELF WITH THE CONDUCTIVE GEL ROLLED INTO A BALL ON THE FRONT/APEX PAD CONDUCTIVE PLATE. OUR INVESTIGATION WAS INCONCLUSIVE ON HOW THIS MAY HAVE OCCURRED. EVALUATION OF THE RETAINS DID NOT REVEAL ANY IRREGULARITIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), WHEN REMOVING THE ELECTRODE PADS FROM THE PACKAGING THE GEL ADHERED TO THE PLASTIC PACKAGING. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODE PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34154 ELECTRODES, STAT PADZ ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-4003 4617 10847946016453

    Patients

    Seq Age Sex Outcome Treatment
    1