BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPR-D PADZ ONE PIECE ELECTRODE PAD WITH REAL CPR

    MDR report key: 14959729 · Received July 8, 2022

    Report

    Report Number
    1218058-2022-00078
    Event Type
    Injury
    Date Received
    July 8, 2022
    Report Date
    June 29, 2022
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    UDI-DI
    00847946000189
    PMA / PMN Number
    K011541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NP
    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

    THIS REPORT WAS INADVERTENTLY SUBMITTED WITH THE INCORRECT DEVICE AND MANUFACTURER INFORMATION. PLEASE REFERENCE MEDWATCH NUMBER 1220908-2022-03880 WITH THE CORRECT DEVICE AND MANUFACTURER INFORMATION.EVALUATION RESULTS:THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. INSTEAD, A PHOTOGRAPH OF THE CUSTOMER'S REPORT WAS PROVIDED. REVIEW OF THE PHOTOGRAPH DID SHOW THE CUSTOMER'S REPORT. HOWEVER, IT WAS DETERMINED THIS WAS AN EXPECTED RESULT GIVEN THE PATIENT PREPARATION STATUS. IF THE PATIENT IS NOT PROPERLY PREPPED THERE CAN BE SKIN BREAKAGE DURING CPR AS THE HAIR IS WRENCHED AND PULLED. A FULL DHR REVIEW FOR THE PART NUMBER AND IDENTIFIED LOTS DID NOT FIND ANY RELATED COMPLAINTS OR DISCREPANCIES. THE CORPULS SENSOR HAS NO THERAPY CAPABILITIES AND THE REDDENING OBSERVED CANNOT BE FROM A BURN FROM THE DELIVERY OF ELECTRICAL THERAPY. THE CORPULS SENSOR HAS UNDERGONE BIOCOMPATIBILITY TESTING DURING IT'S DESIGN TO ENSURE THE MATERIALS BEING USED WERE NOT LIKELY TO CAUSE AN ADVERSE REACTION. FURTHERMORE, THE BENEFIT OF PROVIDING HIGH QUALITY CPR WHEN USING THE ZOLL CPR PUCK VASTLY OUTWEIGHS THE RISK OF RECEIVING SKIN IRRITATION DURING THE CPR PROCESS.ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), AFTER REMOVING THE ELECTRODE PADS, AN ABRASION WAS FOUND ON THE PATIENT'S SKIN. COMPLAINANT INDICATED THAT THE PATIENT SUSTAINED BURN MARKS. NO INFORMATION AVAILABLE TO WHAT DEGREE THE BURNS ARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105524 CPR-D PADZ ONE PIECE ELECTRODE PAD WITH REAL CPR ELECTRODE MKJ BIO-DETEK INCORPORATED 8900-0800-01 UNK 00847946000189

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other