BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPR STAT PADZ

    MDR report key: 5057896 · Received September 4, 2015

    Report

    Report Number
    1218058-2015-00058
    Event Type
    Injury
    Date Received
    September 4, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 17, 2015
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRODE PADS WERE RETURNED FOR EVALUATION. VISUAL EVALUATION SHOWED BLOOD AND SCALY SKIN WERE OBSERVED ON THE CPR PUCK. THE ELECTRODES WERE ELECTRICALLY TESTED AND WERE WITHIN SPECIFICATION. OUR EVALUATION CONCLUDED THAT THERE WERE NO ASSEMBLY OR PERFORMANCE DISCREPANCIES WITH THE ELECTRODES. THE CPR PUCK APPEARED TO BE IN ALIGNMENT WITH THE WIRES AND SCREWS THAT WERE HOLDING THE STERNUM TOGETHER FROM A PREVIOUS CARDIAC SURGERY. IT IS LIKELY THAT WHEN CPR WAS PERFORMED, THE STERNUM MAY HAVE BEEN CRACKED AND THE WIRES AND SCREW ASSEMBLY MAY HAVE CAUSED DAMAGE TO THE SKIN. BROKEN RIBS AND CHEST TRAUMA ARE ACCEPTABLE SIDE EFFECTS TO EFFECTIVE CPR AND ARE CONTRAINDICATED IN THE ELECTRODE LABELING. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    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 AN (B)(6) MALE PATIENT, THAT ALTHOUGH THE DEVICE DID NOT PROVIDE ANY SHOCKS TO THE PATIENT, A DEEP WOUND WAS FOUND ON THE PATIENT SKIN'S UNDER THE ELECTRODE PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588510 CPR STAT PADZ ELECTRODES MKJ BIO-DETEK INCORPORATED 8900-0402 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other