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

Model Number	8416000
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device turned itself off twice during patient use.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
The log file of the affected device was analysed regarding the reported event.The log file analysis could confirm that the cockpit of the device performed three consecutive restarts.As root cause was a faulty ssd identified.The ventilation was not affected by the cockpit restarts.The faulty ssd was 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 a deviation concerning the cockpit, a warm start of the cockpit will be triggered in order to reset the micro processing system to a specified state.A warm start sequence of the cockpit may last 45 seconds.In case that the cockpit restart would take longer, the warm start procedure will be repeated automatically.The ventilation will not be affected by a restarting cockpit and will be continued as set.Safety relevant parameters as fio2, minute volume, or airway pressure are displayed in the supplemental yellow/green oled-display wherein the user can see the on-going ventilation.Monitoring functions and the user interface of the cockpit are not available during the restart.After successful completion of the warm start, the system will post the alarm message ¿cockpit restarted¿ with accompanying audible alarm tone.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that the device turned itself off twice during patient use.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; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 21983399
• Report Number: 9611500-2025-00234
• Device Sequence Number: 15531963
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)160412(17)161231(93)8416400-16
• Combination Product (Y/N): N
• 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): 05/27/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2016
• 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