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

Model Number	8415000
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184); Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while on a patient the display turned red, then shutdown.The ventilator is reported to have kept working.There was not reported patient injury.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
The affected device including its log file were examined onsite by biomed, and the log file was made available for further investigation at the manufacturer¿s site.Based on the device examination and the log file analysis, it was not possible to confirm the reported cockpit malfunction.The log file does not contain any entry indicating a shutdown of the cockpit.On the reported date of event, june 27, 2025, the device was in operation between 04:55 pm and 07:59 pm.During that period, the log entries show, that the user regularly interacted with the device and muted alarms when they occurred.At 07:59 pm the device was switched to standby and shut down via user interface as it is intended.Nevertheless, based on the provided information it 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 therefore recommended to preventively replace the lvds cable.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 while on a patient the display turned red, then shutdown.The ventilator is reported to have kept working.There was not reported patient injury.

• 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: 22802165
• Report Number: 9611500-2025-00448
• Device Sequence Number: 15691041
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)180424(17)181002(93)8417400-16
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: 8415000
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2018
• 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