BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL DL ADAPTER PHILIPS 3 5 LD

    MDR report key: 11640996 · Received April 9, 2021

    Report

    Report Number
    1282497-2021-10041
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 19, 2021
    Report Date
    June 29, 2021
    Manufacturer
    COVIDIEN
    Product Code
    IKD
    UDI-DI
    10884527021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON THE REPORTED DEVICE BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. THE SUPPLIER RECEIVED SIX ADAPTERS OF ITEM CODE 33507 AND ONE CABLE OF ITEM CODE 33135T FOR EVALUATION. AFTER REVIEWING THE RETURNED SAMPLES, THE LOT NUMBER WAS NOT ABLE TO BE FOUND ON THE ADAPTERS. THE LOT NUMBER OF THE CABLE WAS DETERMINED TO BE 072538. THE DEVICE HISTORY RECORD FOR THE CABLE WAS REVIEWED AND THERE HAVE BEEN NO PROCESS CHANGES (INCLUDING INJECTION PARAMETERS/TOOLING/ INJECTION EQUIPMENT). THE SUPPLIER PERFORMED AN ELECTRONIC TEST ON THE ADAPTERS AND CABLE UNDER CURRENT MASS PRODUCTION TEST CONDITIONS. THE SAMPLES PASSED THE TEST AND WERE FOUND TO BE IN GOOD CONDITION. BASED ON THE AVAILABLE INFORMATION THE SUPPLIER WAS UNABLE TO DETERMINE A ROOT CAUSE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS COMPLAINT WILL BE USED FOR 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ONE PATIENT WAS SHOWING A HEART RATE IN THE 30'S. THE NURSE ALMOST PUSHED ATROPIN AND ANOTHER NURSE STATED SHE CHECKED THE LEADWIRES AND "MANIPULATED" THE PINK ADAPTER CONNECTED TO THE MONITOR AND THE PATIENT'S RHYTHM THEN STARTED TO SHOW IT WAS 88. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538807 KENDALL DL ADAPTER PHILIPS 3 5 LD CABLE, ELECTRODE IKD COVIDIEN 33507 10884527021475

    Patients

    Seq Age Sex Outcome Treatment
    1