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

Model Number	8415000
Medical Device Problem Codes	No Display/Image (1183); Decrease in Pressure (1490); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device performed a restart during use on a patient on the (b)(6) 2025.There were no patient health consequences reported.The affected device was removed from patient use.
Additional Manufacturer Narrative
The investigation was started; the results will be provided in a follow-up report.
Additional Manufacturer Narrative
The log file of the affected device was made available and analyzed.The log file shows a communication issue between the cockpit and the ventilation unit on (b)(6) 2025.A malfunction of the cockpit due to a faulty solid-state disk (ssd) was identified as root cause.A restart of the device (ventilation unit) could not be confirmed.The ventilation was not affected by the malfunction of the cockpit and was continued as set until the device was turned off by the user via the rocker switch.The ssd of the device must be replaced.As a safety feature of the system, the safety software analyzes and verifies proper function of the device.If the safety software detects a deviation regarding the cockpit infinity c500, a warm start of the cockpit will be triggered to reset the micro processing system to a specified state.If the hard disk is not accessible during the restart, the boot process of the cockpit cannot be completed.A corresponding error message is displayed, and the acoustic auxiliary alarm is activated after 45 seconds at the latest.The ventilation is not affected by a cockpit malfunction and will be continued as set.Safety relevant ventilation parameters are displayed on the oled-display of the ventilator.In the current event, the device reacted as specified to a malfunction of the cockpit; the auxiliary alarm was activated, and ventilation was continued.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 performed a restart during use on a patient on (b)(6) 2025.There were no patient health consequences reported.The affected device was removed from patient use.

• Brand Name: INFINITY ACS WORKSTATION CNC
• Common Device Name: VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC
• 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: 22026004
• Report Number: 9611500-2025-00250
• Device Sequence Number: 13108976
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)181128(93)8417400-17
• Combination Product (Y/N): N
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2018
• 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