BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPR STAT PADZ HVP MULTI-FUNCTION CPR ELECTRODES -

    MDR report key: 10018617 · Received May 1, 2020

    Report

    Report Number
    1218058-2020-00042
    Event Type
    Injury
    Date Received
    May 1, 2020
    Date of Event
    February 7, 2020
    Report Date
    April 16, 2020
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INADVERTENTLY SUBMITTED AS A DUPLICATE. THE REPORTED EVENT WAS ORIGINALLY REPORTED UNDER MEDWATCH 1220908-2020-00029. THIS CLAIM IS BEING CLOSED AS A DUPLICATE. EVALUATION RESULTS: THE DEVICE WAS NOT RETURNED, INSTEAD THE SUSPECT ELECTRODE PADS WERE RECEIVED FOR EVALUATION. THE ELECTRODES WERE ADHERED TOGETHER WITH THE CPR PUCK IN BETWEEN THE PADS. THE PADS WERE SEPERATED AND VISUALLY INSPECTED. THERE WAS EVIDENCE OF ARCING ON THE OUTER EDGE OF THE STERNUM PAD. THE ENERGY CONCENTRATION OBSERVED ON THE PADS SHOWED THAT THE ENERGY TOOK THE PATH OF LEAST RESISTANCE. WHICH INDICATES THAT THERE WAS POOR COUPLING OF THE ELECTRODE PADS TO THE PATIENT'S SKIN (AIR). THIS REPORT HAS BEEN CLOSED AS POOR COUPLING (CONTINUITY).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), AN ARC OCCURRED AT THE ELECTRODE PADS. AFTER REMOVING THE ELECTRODE PADS, BURNS WERE FOUND ON THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODE PADS TO CONTINUE TREATING THE PATIENT AND AFTER THE SIXTH DEFIBRILLATION, THE DOCTOR STOPPED THE RESUSCITATION. COMPLAINANT INDICATE THAT THE PATIENT SUSTAINED BURNS, THE DEGREE OF PATIENT BURNS AND ANY ADVERSE EFFECT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480674 CPR STAT PADZ HVP MULTI-FUNCTION CPR ELECTRODES - ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0402 UNK 00847946016319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other