BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES

    MDR report key: 4905254 · Received July 2, 2015

    Report

    Report Number
    1218058-2015-00036
    Event Type
    Death
    Date Received
    July 2, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 17, 2015
    Manufacturer
    BIO-DETEK, INC.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS CONTACTED BY ZOLL MEDICAL AND INDICATED THE ELECTRODE PADS USED DURING THIS EVENT WERE DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. NO PRODUCT WAS RETURNED FOR INVESTIGATION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT ADDED VALUE TO OUR INVESTIGATION. THE CUSTOMER STATED THAT DURING THIS EVENT, CPR WAS PERFORMED FOR APPROXIMATELY 27 MINUTES ON A FRAIL (B)(6) YEAR OLD MALE PATIENT. IT WAS REVEALED THE PATIENT HAD CARDIAC SURGERY 12 YEARS AGO AND HAD HARDWARE INSTALLED IN HIS CHEST. IN THE PICTURE PROVIDED BY THE CUSTOMER YOU CAN SEE PERFORATION MARKS THAT ALIGN WITH THE IMPLANTED HARDWARE PREVIOUSLY IMPLANTED DURING CARDIAC SURGERY AND BRUISING. THIS WOULD SUGGEST THAT PRESSURE DURING CPR ON THIS FRAIL PATIENT, ENHANCED THE NEGATIVE AFFECT TO THE PATIENT'S CHEST AREA. HOWEVER, CPR HAS KNOWN RISKS SUCH AS; CHEST SORENESS, BROKEN RIBS, AND COLLAPSED LUNGS. BASED ON THE AVAILABLE INFORMATION IN THIS INVESTIGATION, WE CANNOT COME TO A CONCLUSION THAT THE ELECTRODE PADS MALFUNCTIONED. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING CPR COMPRESSIONS TO A (B)(6) MALE PATIENT, THE PATIENT'S SKIN BEGAN TO BLEED WHERE THE CPR PUCK MADE CONTACT. COMPLAINANT INDICATED THE ELECTRODE PADS USED WERE NOT RETAINED BY THE CUSTOMER. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433125 ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES ELECTRODE MKJ BIO-DETEK, INC. 8900-0224-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death