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

Model Number	8416000
Medical Device Problem Codes	Improper Flow or Infusion (2954); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Increased Respiratory Rate (2486)
Date of Event	07/01/2025
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 intubated pt [patient] on ventilator, not receiving proper support based on settings (alternating tidal volumes, pt tachypneic/irregular resp.[respiratory] rates).Additional sedation was started, testing done, vent alarming continuously d/t [due to] different parameters.Rt [respiratory therapy], rn, md & pa [physician assistant] all in room continuously frequently throughout shift.Paralytic drug ordered and pushed as clinically indicated, did not achieve expected affect as pt was still tachypneic and not receiving adequate tidal volumes.Decision made with team to try switching to a new ventilator with md, pa, rt, and rn at bedside.Once pt switched to new ventilator, the issue was completely resolved.Pt was in synch with vent settings and no longer tachypneic.No patient injury.
Event or Problem Description
It was reported that intubated pt [patient] on ventilator, not receiving proper support based on settings (alternating tidal volumes, pt tachypneic/irregular resp.[respiratory] rates).Additional sedation was started, testing done, vent alarming continuously d/t [due to] different parameters.Rt [respiratory therapy], rn, md & pa [physician assistant] all in room continuously frequently throughout shift.Paralytic drug ordered and pushed as clinically indicated, did not achieve expected affect as pt was still tachypneic and not receiving adequate tidal volumes.Decision made with team to try switching to a new ventilator with md, pa, rt, and rn at bedside.Once pt switched to new ventilator, the issue was completely resolved.Pt was in synch with vent settings and no longer tachypneic.No patient injury.
Additional Manufacturer Narrative
It was reported that an intubated patient was not properly supported with the v500 device.Additional sedation / medication was given.After a device exchange, the pat.Was synch with ventilator settings.The investigation was based on the description of event.A log file could not be provided for further investigation.Therefore, no detailed root cause analysis was possible.A dräger service technician onsite found several communication errors between the c500 and the v500.Also, found that the log of the affected device was not opening properly.He uploaded the software on the cockpit and tested afterwards the device per manufacturer's specifications without any deviations.In case a communication issue could be detected between the c500 and the v500, as reported in this case, are usually logged in connection with cockpit restarts and do not result in ventilation failure.Therefore, a root cause as an application problem is suspected.The service technician onsite tested the device according to manufacturer specs without further deviations.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.

• 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: 23243739
• Report Number: 9611500-2025-00568
• Device Sequence Number: 16057142
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)170613(93)8416400-17
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 8416000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2017
• 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