BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE DUAL CON LEAD SET

    MDR report key: 10900257 · Received November 25, 2020

    Report

    Report Number
    1282497-2020-09662
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Report Date
    February 1, 2021
    Manufacturer
    COVIDIEN
    Product Code
    IKD
    UDI-DI
    10884521212602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4 LOT NUMBER. THE LOT NUMBER WAS DETERMINED THROUGH THE RETURN OF THE PRODUCT FOR EVALUATION. EVALUATION SUMMARY: THE LOT NUMBER WAS NOT KNOWN BY THE CUSTOMER; HOWEVER, THE LOT NUMBER WAS DETERMINED FROM THE RETURNED SAMPLE. THE DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS LOT NUMBER DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. THERE WERE NO PROCESS CHANGES ON PRODUCTION AFTER CHECKING THE ENTIRE PROCESS: INCLUDING INJECTION PARAMETERS, TOOLING, AND INJECTION EQUIPMENT. TWO SAMPLES WERE RECEIVED AT THE MANUFACTURING PLANT FOR EVALUATION WITH LOT NUMBER 060799. TESTING WAS PERFORMED FOR THE CURRENT AND INSULATION. ELECTRICAL TESTING WAS IMPLEMENTED FOR 5 WIRE COMBINATIONS: LL, RL RA, LA, V. THE RETURNED CABLE PASSED THE ELECTRICAL TESTING. THE WELDING QUALITY OF THE CONNECTOR WAS CHECKED BY X-RAY. FROM THE X-RAY RESULT, THERE IS NO ISSUE FOUND FOR WELDING. FROM THE INVESTIGATION IT WAS DETERMINED THE RETURNED CABLE FUNCTION IS NORMAL. ELECTRICAL TESTING WAS PERFORMED ON PRODUCT THAT WAS STORED IN THE MANUFACTURING SITES WAREHOUSE. ALL PRODUCTS PASSED THE ELECTRONIC TESTING. BECAUSE NO ISSUE WAS FOUND WITH THE RETURNED SAMPLES, THE ROOT CAUSE COULD NOT BE DETERMINED. NO ACTION IS BEING TAKEN AT THIS MOMENT. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. THE RESULTS WILL BE SHARED UPON COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT CDH TELEMETRY IS HAVING CONSISTENT ISSUES WITH THE LEADS AND MX40 ADAPTERS CAUSING INCONSISTENT TRACINGS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION PROVIDED STATED THAT THE LEADS WERE PROVIDING INCONSISTENT READINGS, SHOWING "LEADS OFF", AND PROVIDING FALSE ALARMS. THERE WAS NO IMPACT TO THE PATIENT AS A RESULT OF THE INCONSISTENT READINGS. IT IS HARD FOR THE CUSTOMER TO PINPOINT EXACTLY WHAT THE ISSUE IS AS THEY SOMETIMES SWITCH THE ADAPTERS AND SOMETIMES SWITCH THE LEADS OUT. THE ISSUE IS NOT OCCURRING WITH EVERY LEAD SET. IT WAS NOTED THAT THE TELEMETRY BOXES SOMETIMES GO BAD WHERE THE ADAPTERS CONNECT SO THE PINS SOMETIMES DEGRADE. THE CUSTOMER FURTHER STATED THAT BY KEEPING THE ADAPTERS ATTACHED TO THE MONITORS, THEY THINK THEY ARE SEEING IMPROVED TRACINGS. IT IS UNKNOWN IF THE LEADS/ADAPTERS ARE CAUSING THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365621 DISPOSABLE DUAL CON LEAD SET CABLE, ELECTRODE IKD COVIDIEN 33136BT 060799 10884521212602

    Patients

    Seq Age Sex Outcome Treatment
    1