BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    33110E EU DISP 10 LEAD MONITORING SET X5

    MDR report key: 11700972 · Received April 21, 2021

    Report

    Report Number
    1282497-2021-10085
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    April 14, 2021
    Report Date
    July 19, 2021
    Manufacturer
    COVIDIEN
    Product Code
    IKE
    UDI-DI
    10884521516359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS PROVIDED, AND THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED INDICATING THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. THE MANUFACTURING SITE HAS RECEIVED TWO CABLE SETS FOR THE EVALUATION. UNDER CURRENT MASS PRODUCTION TEST CONDITIONS, THE SITE HAS PERFORMED THE ELECTRONIC TEST ON THE RETURNED CABLES, THE TWO CABLE SETS PASSED THE ELECTRONIC TEST. FROM THE INVESTIGATION, THE RETURNED CABLES ARE FUNCTIONAL. BASED ON THE DHRS REVIEW, NO CHANGE OF MATERIAL, TOOLING, PROCESS PROCEDURE AND MACHINE PARAMETER WERE NOTED. THE SITE HAS PERFORMED 100% FUNCTIONAL TEST; THE REPORTED ISSUE CANNOT BE CAUSED BY MANUFACTURING PROCESS BEFORE SHIPMENT. AT THIS TIME, A CORRECTIVE AND PREVENTIVE ACTION IS NOT DEEMED NECESSARY.

    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

    CUSTOMER REPORTS: WHEN THE CUSTOMER USED THE CABLES TO PERFORM AN ECG THERE ARE SOME ARTIFACTS AND THE RESULT IS NOT LEGIBLE. TWO CABLES FROM THE SAME LOT WERE USED IN THE SAME PATIENT WITH THIS PROBLEM. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596754 33110E EU DISP 10 LEAD MONITORING SET X5 TRANSDUCER, MINIATURE PRESSURE IKE COVIDIEN 33110E 025170 10884521516359

    Patients

    Seq Age Sex Outcome Treatment
    1