BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 24567957 · Received March 11, 2026

    Report

    Report Number
    8010762-2026-0000114
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    February 26, 2026
    Report Date
    May 18, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    4037691658384
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN SPAIN DURING PREVENTIVE MAINTENANCE. IT WAS REPORTED THAT THE MACHINE DISPLAYED ERRORS REGARDING ALL VENTILATION FANS, ARTERIAL AND PRESSURE SENSORS DUE TO A DEFECTIVE SENSOR PANEL. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE FAILURE WAS REPORTED, A REPORT IS REQUIRED. COMPLAINT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455975 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I 4037691658384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown