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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the unit was on a patient today, on (b)(6) 2026 and at 3:00 am the unit did a cockpit restart.No reported patient injury.Once powered off it has powered back up.Ventilation continued.
Additional Manufacturer Narrative
The investigation of the provided logfile confirmed cockpit restarts during the reported time.A faulty basis board was the root cause.A replacement of the basis board is recomended and test according to manufacturer specs afterwards.The device reacted as specified on a detected deviation and posted appropriate alarms.The main function of the device - the ventilation - was not interrupted by that issue.The affected device alarmed and behaved as specified.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 cockpit infinity c500, a warm start of the cockpit will be triggered in order to reset the micro processing system to a specified state.A warm start sequence of the cockpit may last 45 seconds.The ventilation will not be affected by a restarting cockpit and will be continued as set.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.Monitoring functions and the user interface of the cockpit are not available during the restart.After successful completion of the warm start, the system will post the alarm message ¿cockpit restarted¿ with accompanying audible alarm tone.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• 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: 24468057
• Report Number: 9611500-2026-00087
• Device Sequence Number: 9326015
• Product Code: BSZ
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)210908(93)8416400-22
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• 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