MAUDE Adverse Event Report: Drägerwerk AG & Co. KGaA Infinity ACS Workstation CC; Ventilators, Intensive Care

Model Number	8416000
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Gas Output Problem (1266); Failure to Deliver (2338); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device made loud clicking noises during use.Values were not displayed on the screen.It was reported that device turned on and off and the patient was not ventilated.The device was eventually replaced.No health consequences for the patient were reported.
Additional Manufacturer Narrative
The investigation was based on the provided log file of the affected device.Based on the log file analysis, the reported device restart and stop of ventilation could not be confirmed.The device posted several alarm messages, e.G., ¿airway pressure high,¿ ¿pressure limited,¿ ¿disconnection?,¿ ¿mv low,¿ and ¿breathing hose kinked.¿ additionally, the message ¿fluid in expiratory valve or pressure measurement failure¿ was raised by the device.The alarm messages indicated an application-related problem, e.G., obstruction or fluid in the expiratory valve and the breathing hose.The log file analysis further revealed that the device performed several pressure releases to protect the patient from too high airway pressure.Also, according to the log file, the anti-air-shower feature was enabled by the user via the system settings.As a result, the flow was automatically reduced due to the detected disconnection.The log file analysis found no indication of a device malfunction.As a safety feature of the system, the safety software analyzes and verifies proper function of the device.If the safety software detects a deviation concerning the pressure measurement, audible and visual alarms would be posted to inform the user about the problem.In case of high airway pressure, a pressure release would be performed to protect the patient.If the anti-air-shower function is enabled by the user and a disconnection is detected during ventilation, the flow will be reduced until reconnection is detected.Simultaneously, the ¿disconnection?¿ alarm is displayed.During disconnection, no ventilation curves are displayed.The ¿anti-air-shower¿ function is described in the instructions for use.The device reacted as specified.Based on the investigation results, this case is assessed to be no longer reportable, as neither a death nor a serious deterioration in the patient¿s state of health occurred, and this is not expected in the event of recurrence, as there was no device malfunction.

• Brand Name: Infinity ACS Workstation CC
• Common Device Name: Ventilators, Intensive Care
• Manufacturer (Section D): Drägerwerk AG & Co. KGaA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): Drägerwerk AG & Co. KGaA; moislinger allee 53-55; lübeck 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; +49(451)8822868
• MDR Report Key: 25824509
• Report Number: 9611500-2026-00370
• Device Sequence Number: 10416967
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)190227(93)8416400-20
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 8416000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown