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

Model Number	8416400
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Gas Output Problem (1266); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 device stopped the ventilation when the nebulizer was activated.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
The log file of the affected device was analysed regarding the reported event.Based on the analysis of the log file the reported ventilation stop could not be confirmed.The log file analysis revealed several ¿disconnection?¿ alarms during the nebulization.Additionally, alarm messages such as ¿airway obstructed?¿, ¿airway pressure low,¿ and ¿leakage¿ were raised by the device.As per log file the anti-air shower function was enable by the user.Consequently, the device reduced the flow delivery due to the detected disconnection.The analysis of the log file found no indication for a device malfunction.The device was tested by the dräger service and confirmed to be operating as per manufacturer´s specification.When the anti air shower function is activated and a disconnection is detected during ventilation, the flow is reduced until a reconnection is detected.Simultaneously, the "disconnection?" alarm is displayed.During a reconnection request there are no graphs displayed.The "anti-air-shower" function is described in the instruction for use.The device reacted as specified on a detected disconnection and posted an appropriate alarm.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 as there was no device malfunction.
Event or Problem Description
It was reported that the device stopped the ventilation when the nebulizer was activated.There were no health consequences for the patient reported.

• Brand Name: INFINITY ACS WORKSTATION CC
• Common Device Name: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA

4518822868

• MDR Report Key: 22932020
• Report Number: 9611500-2025-00483
• Device Sequence Number: 10294612
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)161122(93)8416400-16
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/15/2025

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: 8416400
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2016
• 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