BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60-00302-01 PEDI 1/P 60/CA

    MDR report key: 8887764 · Received August 13, 2019

    Report

    Report Number
    9681860-2019-00506
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Date of Event
    July 31, 2019
    Report Date
    November 21, 2019
    Manufacturer
    COVIDIEN
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PAIR OF ELECTRODES WERE RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. THE SAMPLE ARRIVED IN AN OPENED POUCH. THE PRODUCT ID AND LOT NUMBER MATCHED THE INFORMATION THAT WAS RECEIVED WITH THE COMPLAINT. WE TRIED TO REPLICATE THE REPORTED ISSUE BY RERUNNING BACK THROUGH THE PROGRAMMING FIXTURE. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE PROGRAMMING SOFTWARE WAS ABLE TO READ THE INFORMATION OFF OF THE DEVICE WITH NO ISSUES OBSERVED. THE SOFTWARE RETURNED THE CORRECT MANUFACTURING LOT NUMBER AND MODEL NUMBER. WE DO NOT KNOW IF THE X, Y, AND Z ACCESS INFORMATION OF (B)(4) IS CORRECT WITHOUT UNDERSTANDING WHAT INFORMATION IS BEING PROGRAMMED INTO THE DEVICE FOR THESE FIELDS. WHEN TRYING TO REPROGRAM THE DEVICE WE RECEIVED A PROGRAMMING DEVICE STATUS FAILURE HOWEVER WE DO NOT KNOW IF THIS IS A DEVICE DEFECT OR IF THERE IS A SINGLE FLASH PROGRAMMING CHIP THAT WILL NOT ALLOW MORE THAN ONE PROGRAM FLASH. THE REPORTED ISSUE APPEARS TO BE ASSOCIATED WITH THE USER. WITHOUT A SAMPLE THAT DISPLAYS THE REPORTED CONDITION OR A SAMPLE IN WHICH THE REPORTED CONDITION CAN BE DUPLICATED, THE ROOT CAUSE CANNOT BE POSITIVELY ATTRIBUTED TO A PRODUCT DESIGN OR MANUFACTURING PROBLEM. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ELECTRODE WAS TESTED TWICE AND FAILED DUE TO A CONNECTION ERROR. THERE WAS NO HARM TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681860 60-00302-01 PEDI 1/P 60/CA AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ COVIDIEN 40000058 190531-01

    Patients

    Seq Age Sex Outcome Treatment
    1