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

Model Number	8415000
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was based on the log file of the affected device.Based on the log file analysis the reported device shutdown could not be confirmed.The log file analysis revealed a communication problem between the cockpit and the ventilation unit of the device.A temporary access problem on the hard drive that caused a temporary loss of cockpit function was identified as root cause.The ongoing ventilation was not interrupted during the reported event.The solid-state drive should be replaced.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.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.Monitoring functions and the user interface of the cockpit are not available.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 during use, the cockpit went blank and rebooted.There was 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: 23289760
• Report Number: 9611500-2025-00573
• Device Sequence Number: 20213661
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)180410(93)8417400-16
• 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): 10/14/2025

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: 8415000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2018
• 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