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

Model Number	8417400
Medical Device Problem Codes	Complete Blockage (1094); Gas Output Problem (1266); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device failure occurred during use.This situation was alarmed by the device.It was further reported that a circuit disconnection frequently occurred prior to the device failure.There were no patient health consequences reported.
Additional Manufacturer Narrative
The log file of the affected device was made available and analyzed for investigation.Based on the log file analysis it could be confirmed that the alarm ¿device failure¿ was posted at 10:20 a.M.On the (b)(6) 2025.In addition, alarms such as "airway pressure low" and "disconnection?" were issued by the device.The alarm message ¿device failure¿ was caused by a detected significant difference between the measured inspiratory and expiratory airway pressure greater than 5 mbar.In reaction to this deviation in the pressure measurements the device preformed a pressure release (the safety valve opens to ambient).The log file entries indicate an application issue as root cause of the detected significant difference in expiratory and inspiratory pressure.There was no technical malfunction of the device found as root cause for this event.As a safety feature of the system, the safety software analyses and verifies proper function of the device.In case the safety software detects a deviation concerning the pressure measurement system, the emergency-breathing valve would open to ambient allowing for spontaneous breathing.Audible alarms are posted to alert the user of the situation.Manual ventilation with an alternate device may be considered necessary.In the current event, the device reacted as specified and generated a corresponding alarm message.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: 21570593
• Report Number: 9611500-2025-00115
• Device Sequence Number: 12996891
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)141016(93)8417400-13
• Combination Product (Y/N): N
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/11/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2014
• 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