MAUDE Adverse Event Report: Maquet Cardiopulmonary GmbH Cardiohelp; Console, Heart-Lung Machine, Cardiopulmonary Bypass

Model Number	Cardiohelp
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event was occurred in france during installation.It was reported that the cardio help displayed the error message "case 2 fan defective." on (b)(6) 2026, on the provided logfiles of the cardio help device it was found that drive fan 2, housing fan 1 and housing fan 2 defective.No harm to any person has been reported.As both fans of the same type are affected, improper cooling of the product can occurred, therefore a report is required.Complaint #(b)(4).
Additional Manufacturer Narrative
A getinge technician was sent for investigation.Technician confirms that the faulty fan is one of the 2 located on the engine on the outside, however both fans were replaced as a precaution.The technician performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.During the review of the logfiles, it was found that drive fan 1 and drive fan 2 were defective, a further clarification is pending from technician.The investigation is ongoing.A follow up medwatch will be submitted when further information becomes available.Note: this event occurred on the france 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.

• Brand Name: Cardiohelp
• Common Device Name: Console, Heart-Lung Machine, Cardiopulmonary Bypass
• Manufacturer (Section D): Maquet Cardiopulmonary GmbH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): Julia Kapfenberger; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 50750812
• Report Number: 8010762-2026-0000552
• Device Sequence Number: 8861680
• Product Code: DTQ
• UDI-Device Identifier: 04037691658384
• UDI-Public: (01)04037691658384
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Cardiohelp
• Device Catalogue Number: 701048012
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 08/12/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown