BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT PADZ II ADULT

    MDR report key: 4756425 · Received May 1, 2015

    Report

    Report Number
    1218058-2015-00011
    Event Type
    Malfunction
    Date Received
    May 1, 2015
    Date of Event
    March 22, 2015
    Report Date
    April 10, 2015
    Manufacturer
    BIO-DETEK, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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 DEFIBRILLATE A (B)(6) MALE PT, THE ELECTRODES WOULD NOT ADHERE TO THE PT'S SKIN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289697 STAT PADZ II ADULT ELECTRODES MKJ BIO-DETEK, INC. 8900-0801-01 3715

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR