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

Model Number	8416000
Medical Device Problem Codes	Gas Output Problem (1266); Decrease in Pressure (1490); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2025
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 affected device had performed a restart while used on a patient.There were no patient health consequences reported.
Event or Problem Description
It was reported that the affected device had performed a restart while used on a patient.There were no patient health consequences reported.
Additional Manufacturer Narrative
The log file of the affected device was made available and analyzed.Based on the log file analysis, the reported event could be confirmed: the log file shows that the device performed a restart of the ventilation unit at 6:51 pm on (b)(6) 2025.Alarm messages such as ¿device failure 3¿, ¿device failure 9¿ and ¿device failure 11¿ were logged in addition.At 6:52 pm, the device was switched to standby mode by the user.A faulty pba m16.2 and a faulty the cf-card were identified as root cause of the device restart.The faulty parts must be replaced to remedy the issue.As a safety feature of the system, the safety software analyses and verifies proper function of the device.If the safety software detects an internal failure concerning the ventilator, a local restart of the ventilation unit is triggered.If the ventilation stops, the emergency-breathing valve opens to ambient allowing for spontaneous breathing.Audible alarms are posted to inform the user about the problem.If the ventilation unit cannot be successfully reset within the first 8 seconds, a further reset is triggered.After three ineffective restarts, the system automatically switches off with accompanying alarms.The emergency-breathing valve remains open allowing for spontaneous breathing.However, manual ventilation with an alternate device may be considered necessary.In the current event, the device reacted as specified to a detected internal failure; it performed a restart and posted accompanying alarm messages to inform the user about a problem.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: 23530140
• Report Number: 9611500-2025-00622
• Device Sequence Number: 18688685
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)170907(93)8416400-18
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: 8416000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2017
• 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