BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDI PADZ II PEDIATRIC MALTI-FUNCTION ELECTRODES

    MDR report key: 4731043 · Received April 21, 2015

    Report

    Report Number
    1218058-2015-00005
    Event Type
    Malfunction
    Date Received
    April 21, 2015
    Date of Event
    March 7, 2015
    Report Date
    March 31, 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 TREAT A PT (AGE AND GENDER UNK) THE ELECTRODES WOULD NOT ADHERE TO THE PT'S SKIN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF PADS TO CONTINUE TREATING THE PT. 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
    263382 PEDI PADZ II PEDIATRIC MALTI-FUNCTION ELECTRODES ELECTRODE MKJ BIO-DETEK, INC. 8900-0810 0515

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK