BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAT PADZ HVP MULTI FUNCTION ELECTRODES

    MDR report key: 6145690 · Received December 5, 2016

    Report

    Report Number
    1218058-2016-00148
    Event Type
    Death
    Date Received
    December 5, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 16, 2016
    Manufacturer
    BIO-DETEK INCORPORATED
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE PACKAGING OF THE ALLEGED ELECTRODE PAD AND THE CUSTOMERS REPORT WAS NOT VERIFIED. EVALUATION OF THE PACKAGING DID SHOW EVIDENCE TO INDICATE THE ELECTRODES WERE PRESENT AT THE TIME OF MANUFACTURING. DUE DILIGENCE CONFIRMED THAT MULTIPLE MONITORS AND DETECTIONS ARE EMBEDDED WITHIN THE ASSEMBLY PROCESS TO ASSURE ELECTRODES ARE PRESENT IN EVERY PACKAGE. EVALUATION OF THE RETAINED SAMPLE CONFIRMED NO DISCREPANCIES. THIS REPORT HAS BEEN CLOSED AS UNSUBSTANTIATED. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A MALE PATIENT (AGE UNKNOWN) FOR CARDIAC ARREST, A SET OF STAT- PADZ WAS OPENED AND ELECTRODES WERE FOUND TO BE MISSING FROM THE PACKAGE. A SECOND SET WAS OPENED, BUT WITH THE SAME ISSUE. A THIRD WAS THEN OPENED AND WAS ABLE TO BE APPLIED ONTO THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795729 STAT PADZ HVP MULTI FUNCTION ELECTRODES DEFIB/PACING ELECTRODE MLN BIO-DETEK INCORPORATED 8900-4004 0916

    Patients

    Seq Age Sex Outcome Treatment
    1 Death