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

Model Number	8416000
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
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
The following was reported: (b)(6) 2025 ~11:09:16~while on a patient unit alarmed "device failure (1)" and shutdown.Therapist was near room when the unit alarmed and shutdown.At the present time, a stopp of ventilation cannot be excluded.No pat.Health consequences have been 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 not be confirmed.The log file analysis showed that the device was not in ventilation mode on november 25, 2025.Furthermore, no failure entries were identified in the log file on this date.The log file showed that on november 23, 2025, the device performed a reboot due to a faulty pba therapy control unit.The event was investigated separately under mdr report no.9611500-2025-00695.The faulty pba and cf-card were already replaced by the dräger service.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.Based on the investigation results this case is assessed to be not reportable anymore as neither a death nor a serious deterioration in the patient's state of health occurred and this is not to be expected in the event of a recurrence.
Event or Problem Description
The following was reported: 2025-11-25~11:09:16~while on a patient unit alarmed "device failure (1)" and shutdown.Therapist was near room when the unit alarmed and shutdown.At the present time, a stop of ventilation cannot be excluded.No pat.Health consequences have been 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: 23825711
• Report Number: 9611500-2025-00696
• Device Sequence Number: 14722734
• 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?: No
• 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