BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 11684578 · Received April 19, 2021

    Report

    Report Number
    8010762-2021-00255
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    April 1, 2021
    Report Date
    April 19, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED AN IMPAIRED FUNCTIONALITY OF THE CARDIOHELP TOUCHSCREEN. THE CUSTOMER REPLACED THE CARDIOHELP DEVICE AND CONTINUED THE PROCEDURE WITHOUT ANY ADVERSE EFFECT ON THE PATIENT. A GETINGE FIELD SERVICE TECHNICIAN WAS SENT FOR INVESTIGATION ON 2021-04-07. HE COULD CONFIRM THE REPORTED FAILURE AND CALIBRATED THE TOUCHSCREEN. THE UNIT WAS TESTED AND PUT BACK IN USE. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2021-04-12 FOR THE PERIOD OF 2013-02-01 TO 2021-04-12. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES CAN BE EXCLUDED. LOG FILES ANALYSIS OF THE CARDIOHELP SYSTEM WAS PERFORMED ON 2021-04-14. THE LOG FILES SHOWS THAT THE DEVICE HAD NO MALFUNCTION. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE COULD BE CONFIRMED, BUT A ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, THE IMPAIRED FUNCTIONALITY OF THE CARDIOHELP TOUCHSCREEN CAN BE LINKED TO THE FOLLOWING MOST PROBABLE ROOT CAUSE ACCORDING TO OUR RISK ANALYSIS: LOST TOUCH CALIBRATION. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. 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 · 1

    THE CUSTOMER REPORTED AN IMPAIRED FUNCTIONALITY OF THE CARDIOHELP TOUCHSCREEN. THE CUSTOMER REPLACED THE CARDIOHELP DEVICE AND CONTINUED THE PROCEDURE WITHOUT ANY ADVERSE EFFECT ON THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586535 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP BASE UNIT

    Patients

    Seq Age Sex Outcome Treatment
    1