MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	CARDIOHELP-I
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the touchscreen cracked during transportation of the cardiohelp.The cardiohelp fell over and therefore the touchscreen cracked.No harm to any person has been reported.As the device was replaced during treatment, a report is required.Following patient dates were provided: female, 49 years, weight is unknown.A getinge technician was sent for investigation.The ch assembly touch foil & display will be replaced.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).This analysis is also supported by the cardiohelp risk analysis v24.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 5.6.1 "check before every application" the touch screen must be checked before use.The device was manufactured on 2021-11-22.The review of the non-conformities has been performed on 2026-02-03 for the period of 2021-11-22 to 2025-12-22.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 "cracked touschscreen" could be confirmed,but it was not a malfunction of the device.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.
Event or Problem Description
Complaint id: (b)(4).
Event or Problem Description
The event occurred in usa during treatment.It was reported that the touchscreen cracked during transportation of the cardiohelp.The cardiohelp fell over and therefore the touchscreen cracked.No harm to any person has been reported.As the device was replaced during treatment, a report is required.Complaint id: (b)(4).
Additional Manufacturer Narrative
The cardiohelp is out of use and was shipped to the getinge repair depot for repair.A follow up will submitted, when additional information becomes available.
Event or Problem Description
Complaint id: (b)(4).
Additional Manufacturer Narrative
Patient dates were provided: female, 49, weight is unknown.A follow up will submitted when addtional information become available.

• 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: 24114291
• Report Number: 8010762-2026-0000020
• Device Sequence Number: 9371701
• Product Code: DTQ
• UDI-Device Identifier: 04058863074863
• UDI-Public: (01)04058863074863(11)211122
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2026

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-I
• Device Catalogue Number: 701072780
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2026
• Supplement Date Received by Manufacturer: 01/30/2026; 02/02/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 01/30/2026; 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 49 KG