BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 25216954 · Received May 19, 2026

    Report

    Report Number
    8010762-2026-0000237
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    May 12, 2026
    Report Date
    May 19, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    4037691658384
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE SERVICE TECHNICIAN WILL INVESTIGATE THE AFFECTED CARDIOHELP. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE UNITED KINGDOM 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.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN UNITED KINGDOM, PRIOR TO USE. IT WAS REPORTED THAT THERE WAS A FAULTY FLOW SENSOR. INFORMATION RECEIVED ON 2026-05-13 THAT THE VENOUS BUBBLE SENSOR WAS THE AFFECTED PART. THE VENOUS BUBBLE SENSOR WAS DAMAGED AND BROKEN AND NEEDED REPLACEMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A BUBBLE SENSOR DEFECTIVE ALARM COULD LEAD TO A ZERO FLOW MODE, A REPORT IS REQUIRED. COMPLAINT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248482 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I 4037691658384

    Patients

    Seq Age Sex Outcome Treatment
    1