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

Model Number	8416000
Medical Device Problem Codes	No Display/Image (1183); Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screen of the affected device had gone blank while it was on a patient.The ventilator continued to ventilate.No patient health consequences reported.
Additional Manufacturer Narrative
The log file of the affected device was provided for the investigation.Based on the log file analysis, the reported cockpit issue could be verified.A faulty or disconnected lvds cable was identified as root cause of the temporary screen malfunction.As the screen reportedly turned blank, the user switched the device off by using the rocker switch.After the device was switched on again, user interactions via the screen were logged indicating that the cockpit was operable again.It was recommended to check the screen and the cable harness including lvds cable and replace them if necessary.In case of a screen malfunction, monitoring functions and the user interface of the cockpit are not available.The running ventilation is not affected by such an issue and continues as previously set.Safety relevant parameters as fio2, minute volume, or airway pressure are displayed in the supplemental oled-display located on the ventilation unit and it includes an indicator for the on-going ventilation which the user can see.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: 23389163
• Report Number: 9611500-2025-00597
• Device Sequence Number: 9871665
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)200914(17)210729(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
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown