MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION CC; VENTILATORS, INTENSIVE CARE

Model Number	8416000
Medical Device Problem Codes	No Display/Image (1183); Failure to Read Input Signal (1581); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
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 device is stopped during ventilation and has rebooted repeatedly.No patient injury was reported.
Additional Manufacturer Narrative
The investigation was based on the reported information and log file of the affected device.On the reported date of event 10th september the device was switched off and not in use.However, a cockpit reboot could be found on a different day due to faulty ssd and hdd which corresponds with the report issue.Other than reported, ventilation was not affected by the malfunction and continued as set.The affected parts were replaced which solved the problem.The device was tested according to manufacturer specification and all tests passed with no issues.If the disk drive is not accessible for the microprocessor system, the safety software initializes a warmstart of the cockpit infinity c500.If the disk drive is not accessible even during the warm start, the cockpit's boot process cannot be completed.A corresponding error message is displayed on the black screen and the acoustic auxiliary alarm is activated after 45 seconds at the latest.The ventilation is not affected by a warmstart of the cockpit.Safety relevant parameters as fio2, minute volume, or airway pressure are displayed in the supplemental yellow/green oled-display wherein 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 device is stopped during ventilation and has rebooted repeatedly.No patient injury was reported.

• 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 ; 4518822868
• MDR Report Key: 23580965
• Report Number: 9611500-2025-00633
• Device Sequence Number: 9398708
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)190527(17)200311(93)8416400-20
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2026

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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2019
• 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
• Patient Sex: Unknown