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); Failure to Deliver (2338); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported: shutdown on patient and rebooted, when it came up it showed "device failure 1".Event occurred (b)(6) 2025, time 13:00, no adverse patient effects reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
The following was reported: shutdown on patient and rebooted, when it came up it showed "device failure 1".Event occurred 11-23-2025, time 13:00, no adverse patient effects reported.
Additional Manufacturer Narrative
The affected device was examined onsite by the dräger service and the log file was secured for further investigation.Based on the analysis of the log file the reported event could be confirmed.The log file analysis has shown that the device detected an internal failure on november 23, 2025 around 1 pm.As a result, the ventilation unit performed a reboot for mitigation.However, as the reboot could not mitigate the issue the device raised the alarm messages "device failure (1)", "device failure (12)" and the ventilation related alarm "mv low".The ventilation was eventually switched to standby mode by the user.Examination of the device by the dräger service found the pba therapy control unit as cause for the failure.The faulty pba and the cf-card were replaced.The device was tested and confirmed to be operating as per manufacturer¿s specification.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 would be triggered.In the event that the device stops ventilation, the emergency-breathing valve would open to ambient allowing for spontaneous breathing.Audible alarms would be posted to inform the user about the problem.If the ventilation unit could not be successfully reset within the first 8 seconds, a further reset would be triggered.After three ineffective reboots, the system would be automatically switched off with accompanying alarms.The emergency-breathing valve remains opened allowing for spontaneous breathing.However, manual ventilation with an alternate device may be considered necessary.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: 23825708
• Report Number: 9611500-2025-00695
• Device Sequence Number: 5080781
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)191111(17)200426(93)8416400-21
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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): Follow-Up
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2019
• 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