BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE STEP COMPLETE ELECTRODE, 8 PER CASE

    MDR report key: 15348143 · Received September 2, 2022

    Report

    Report Number
    1218058-2022-00093
    Event Type
    Death
    Date Received
    September 2, 2022
    Date of Event
    July 29, 2022
    Report Date
    August 15, 2022
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946016272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION EVALUATED THE ELECTRODE PADS AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. EVALUATION OF THE CPR PUCK DID NOT FIND ANY SHARP SURFACES ON THE PUCK. IT CANNOT BE DETERMINED IF THE PADS CONTRIBUTED TO THE REPORTED INJURY. ATTEMPTS WERE MADE TO CONFIRM THE PRESENCE OF INTERNAL HARDWARE WITH THE CUSTOMER BUT THIS WAS UNSUCCESSFUL. THERE IS NO INDICATION OF A DEVICE MALFUNCTION ASSOCIATED WITH THE RETURNED ELECTRODES. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A MALE PATIENT (AGE UNKNOWN), UPON REMOVAL OF THE PADS, A HOLE WAS FOUND ON THE PATIENT'S CHEST WHERE THE CPR PUCK WAS POSITIONED. NO FURTHER INFORMATION WAS AVAILABLE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809087 ONE STEP COMPLETE ELECTRODE, 8 PER CASE ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0214-01 UNK 00847946016272

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death