BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 24812797 · Received April 8, 2026

    Report

    Report Number
    8010762-2026-0000160
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 26, 2026
    Report Date
    May 28, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    UDI-DI
    04037691658384
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 AUSTRALIEN 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 AUSTRALIA. IT WAS REPORTED, THAT THE PVEN (PRESSURE VENOUS) EXTERNAL DATA INPUTS RECEIVED FROM THE SERVICE KIT SENSOR MODEL, ARE NOT BEING DISPLAYED ON THE CARDIOHELP SCREEN. THE FAILURE WAS DETECTED DURING MAINTENANCE. THE SENSOR PANEL WILL BE REPLACED. NO HARM TO ANY PERSON HAS BEEN REPORTED.COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312975 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I 04037691658384

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown