BEUDAMED
    FDA Adverse Event Death Summary report: N

    CPR DURA PADZ, REUSABLE DEFIBRILLATION ELECTRODE

    MDR report key: 8647295 · Received May 28, 2019

    Report

    Report Number
    1218058-2019-00051
    Event Type
    Death
    Date Received
    May 28, 2019
    Date of Event
    January 31, 2019
    Report Date
    May 7, 2019
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE LOGS WERE RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. REVIEW OF THE PROVIDED DEVICE LOG DID CONFIRM THAT THE ECG SIGNAL WAS NOT CONSISTENTLY ACQUIRED DUE TO POOR COUPLING, PREVENTING THE DEVICE FROM DELIVERING ENERGY INTERMITTENTLY. EVALUATION OF THE RETURNED ELECTRODES (SR712148) DID NOT IDENTIFY ANY ASSEMBLY DISCREPANCIES. THE IFU (R2129-13) STATES: 12: TO ENSURE PROPER ADHESION, DO NOT REPOSITION ELECTRODES ONCE ADHERED TO PATIENT. IF REPOSITIONING IS REQUIRED, USE A NEW SET OF DURA-PADZ GEL. 14: AFTER PATIENT MOVEMENT DUE TO MUSCLE CONTRACTION OR PATIENT REPOSITIONING, PRESS ELECTRODES FIRMLY TO SKIN TO ENSURE GOOD COUPLING IS MAINTAINED. 15: DO NOT PERFORM CHEST COMPRESSIONS DIRECTLY OVER THE ELECTRODES, AS THIS MAY CAUSE DAMAGE TO THE DEVICE. THE DEVICE PASSED FINAL TEST, WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A MALE PATIENT (AGE UNKNOWN), THE ASSOCIATED DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL USING THESE ELECTRODE PADS. THE ELECTRODE PADS AND GEL APPEARED TO LIFT OFF THE PATIENT'S CHEST CAUSING THE ASSOCIATED DEVICE UNABLE TO ANALYZE THE PATIENT'S RHYTHM. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. PLEASE REFERENCE MEDWATCH REPORT 1218058-2019-00057 AND 1218058-2019-00052 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441805 CPR DURA PADZ, REUSABLE DEFIBRILLATION ELECTRODE ELECTRODES MKJ BIO-DETEK INCORPORATED 8900-000310 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death