BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 19319262 · Received May 15, 2024

    Report

    Report Number
    8010762-2024-00271
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 14, 2024
    Manufacturer
    JULIA KAPFENBERGER
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE CARDIOHELP SENSOR PANEL NEEDS REPLACEMENT FOLLOWING A FAILED PATIENT LEAKAGE TEST DURING PREVENTIVE MAINTENANCE. NO HARM TO ANY PERSON HAS BEEN REPORTED. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION. THE SENSOR PANEL WILL BE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THIS COMPLAINT IS IN SCOPE OF FSCA# 881841. BASED ON THE RESULTS THE REPORTED FAILURE "FAILED ELECTRICAL LEAKAGE TEST" COULD BE CONFIRMED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿ S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOHELP SENSOR PANEL NEEDS REPLACEMENT FOLLOWING A FAILED PATIENT LEAKAGE TEST DURING PREVENTIVE MAINTENANCE. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483824 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ CARDIOHELP.I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown