MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION NC; VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC

Model Number	8417400
Medical Device Problem Codes	No Display/Image (1183); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the display of the device turned off during use.It was not rebooting.Reportedly, the ventilation was not interrupted.No health consequences for the patient were reported.
Additional Manufacturer Narrative
The affected cockpit of the device was examined at the local dräger repair centre.The examination of the cockpit could confirm the reported failure.A faulty display was identified as root cause.The faulty display, as well as the touch screen and rotary knob were replaced.The device was tested and confirmed to be operating as per manufacturer´s specification.In case of a display malfunction, monitoring functions and the user interface of the cockpit are not available.The running ventilation is not affected by such an issue and continues as previously set.Safety relevant parameters as fio2, minute volume, or airway pressure are displayed in the supplemental oled-display and the user can see the on-going ventilation.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that the display of the device turned off during use.It was not rebooting.Reportedly, the ventilation was not interrupted.No health consequences for the patient were reported.

• Brand Name: INFINITY ACS WORKSTATION NC
• Common Device Name: VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC
• 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 ; 4518822868
• MDR Report Key: 24256402
• Report Number: 9611500-2026-00038
• Device Sequence Number: 12848589
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)200914(17)210120(93)8417400-19
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093632
• 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): 03/02/2026

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: 8417400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2020
• 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.; NA.
• Patient Sex: Unknown