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

Model Number	8415000
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	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the screen of the device turned blank.There were no health consequences for the patient reported.
Event or Problem Description
It was reported that the screen of the device turned blank.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
The affected device was examined by the dräger service and the log file was made available for further investigation.The examination of the device by the dräger service could confirm a loss of function of the cockpit of the device.A faulty main basis board was identified as root cause.The main basis board was already replaced.Additionally, the base image and software were loaded, and the touch screen was calibrated.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.The ventilation is not affected by a warm start of the 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 track the on-going ventilation.After successful completion of the warm start, the system will post the alarm message «cockpit restarted» with accompanying audible alarm tone.A warm start sequence of the cockpit may last 45 seconds.If it would take longer, the warm start procedure will be repeated automatically.After three unsuccessful attempts, the workstation would stop restarting the cockpit 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.

• Brand Name: INFINITY ACS WORKSTATION NC
• 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: 22175544
• Report Number: 9611500-2025-00294
• Device Sequence Number: 18097310
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)201012(93)8417400-19
• 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): 07/07/2025

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: 05/13/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2020
• 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
• Patient Sex: Unknown