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

Model Number	8416400
Medical Device Problem Codes	No Display/Image (1183); Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
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 there was a screen malfunction noticed while the device was in use.The screen first flickered between black and white, and then blacked out completely.After turning the power on again, the screen did not come back on.Reportedly, the ventilation was working.There were no patient health consequences reported.
Additional Manufacturer Narrative
The affected device was examined onsite by dräger service, and the log file was made available for further investigation at the manufacturer¿s site.The log file shows that the device was in operation between (b)(6) 2025 (09:05 am) and (b)(6) 2025 (7:55 am).During that period, the log entries show, that the user regularly interacted with the device and muted alarms when they occurred.Based on the provided information it, however, cannot be excluded that a temporary malfunction of the cockpit screen had happened e.G., most likely cause by an impaired lvds cable or cable connection (between the basis-boards and the display).It was recommended to check the lvds cable and replace it, if necessary.A faulty lvds cable (between the basis-boards and the display) can cause the display to appear blank, red or with lines.The running ventilation is not affected by a cockpit failure like reboot, no boot, red tint, black screen or flickering screen and affects only its display.Safety relevant ventilation parameters are displayed in the supplemental oled-display and the user can see the on-going ventilation.Monitoring functions and the user interface of the cockpit, however, are not available.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 there was a screen malfunction noticed while the device was in use.The screen first flickered between black and white, and then blacked out completely.After turning the power on again, the screen did not come back on.Reportedly, the ventilation was working.There were no patient health consequences 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: 22951125
• Report Number: 9611500-2025-00492
• Device Sequence Number: 21299065
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)161107(17)171007(93)8416400-16
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/28/2025

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: 8416400
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2025
• 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