MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION NC; VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC

Model Number	8417400
Medical Device Problem Codes	No Display/Image (1183); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The log file of the affected device was analysed regarding the reported event.Based on the log file analysis the reported event could be confirmed.The log file revealed a communication problem between the cockpit and the ventilation unit of the device.This indicates an access problem on the hard drive that caused a boot error during the cockpit restart, causing a temporary loss of cockpit function while ventilation was in progress.The solid state disc (ssd) and the bios battery have already been replaced by the dräger service.The device was tested and confirmed to be operating as per manufacturers specifications.If the hard disk is not accessible for the microprocessor system, the safety software initializes a warm start of the cockpit.If the hard disk is not accessible even during the warm start, the cockpit's boot process cannot be completed.A corresponding error message is displayed on the black screen and the acoustic auxiliary alarm is activated after 45 seconds at the latest.In this case, the ventilation continues with the set parameters.Monitoring functions and the user interface of the cockpit are not available.Safety-relevant parameters such as fio2, minute volume or airway pressure are displayed in the additional oled display, in which the user can see the ongoing ventilation.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 display of the device blanked out.It stated rebooting and asked to insert a bootable medium.There were no health consequences for the patient reported.

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

4518822868

• MDR Report Key: 23003661
• Report Number: 9611500-2025-00507
• Device Sequence Number: 21104603
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)160126(93)8417400-14
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093632
• 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): 09/09/2025

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: 8417400
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2016
• 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