BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 23297977 · Received October 15, 2025

    Report

    Report Number
    8010762-2025-0000455
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    October 13, 2025
    Report Date
    October 22, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    04037691658384
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP WILL SUBMITTED WHEN ADDITIONAL INFORMATION BECOME AVAILABLE.NOTE: THIS EVENT OCCURRED ON THE HONG KONG MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, CARDIOHELP¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K133598. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR CARDIOHELP WITH CATALOG NUMBER 701048012.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE TOUCHSCREEN IS BROKEN. THE FAILURE OCCURRED DURING PATIENT TRANSPORT. THE CARDIOHELP WAS EXCHANGED DURING TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED.AS THE CARDIOHELP WAS EXCHANGED, A REPORT IS NEEDED.A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION. THE CH ASSEMBLY TOUCH FOIL & DISPLAY WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. BASED ON THE INVESTIGATION RESULTS THIS REPORTED DAMAGE ON THE SCREEN IS MOST PROBABLY RELATED TO ROUGH HANDLING OF THE DEVICE, WHICH LEADS TO THE MECHANICAL DAMAGE. (E.G. SOMETHING HIT THE SCREEN). IT WAS CONFIRMED THAT AGAINST THE IFU, THE DISPLAY WAS NOT COVERED WITH THE PROTECTION COVER.THIS ANALYSIS IS ALSO SUPPORTED BY THE CARDIOHELP RISK ANALYSIS. THE CARDIOHELP HAS SEVERAL SAFETY FEATURES, THAT THE DEVICE CAN BE OPERATED, EVEN WHEN THE TOUCH SCREEN DOES NOT WORK ANYMORE. ALL-IMPORTANT ADJUSTMENTS CAN BE MADE BY USING THE ROTARY KNOB OR IF ALL OTHER THINGS DO NOT WORK BY ENGAGING THE EMERGENCY MODE TO KEEP UP THE BLOOD FLOW. FURTHER ACCORDING TO THE INSTRUCTION FOR USE (IFU) OF THE CARDIOHELP SYSTEM, CHAPTER "CHECK BEFORE EVERY APPLICATION" THE TOUCH SCREEN MUST BE CHECKED BEFORE USE.ACCORDING TO THE IFU, CHAPTER "INTER-HOSPITAL PATIENT TRANSPORTATION", THE CARDIOHELP-I HAS DEGREE OF PROTECTION ACCORDING TO IEC 60529 OF IPX1 (NO PROTECTION AGAINST SPLASH WATER). FOR PATIENT TRANSPORT, THE USE OF THE PROTECTION COVER IS REQUIRED. THE DEVICE WAS MANUFACTURED ON 2020-02-04.THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-10-17 FOR THE PERIOD OF 2020-02-04 TO 2025-10-13. 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 ARE UNLIKELY. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS.BASED ON THE RESULTS THE REPORTED FAILURE "TOUCHSREEN IS BROKEN" COULD BE CONFIRMED, BUT ITS NOT A PRODUCT RELATED MALFUNCTION.THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT.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 TOUCHSCREEN IS BROKEN. THE CARDIOHELP WAS EXCHANGED DURING TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED.COMPLAINT ID:(B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021206 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I 04037691658384

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female