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

Model Number	8417400
Medical Device Problem Codes	Gas Output Problem (1266); Decrease in Pressure (1490); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device restarted and generated a piezo alarm.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
The log file of the affected device was analysed regarding the reported event.The analysis of the log file could confirm that the ventilation unit of the device performed a restart in operation mode during the reported date of event.After the successful restart, the ventilation automatically resumed and continued with the latest settings.The restart of the ventilation unit was caused by a malfunction of the therapy control unit pcb.The faulty pcb must be replaced to resolve the failure.As a safety feature of the system, the safety software analyses and verifies proper function of the device.If the safety software detects an internal failure concerning the ventilator, a restart of the ventilation unit will be triggered with accompanying alarm.The restart sequence lasts for a maximum of 8 seconds.During that time the emergency-breathing valve remains open to ambient allowing for spontaneous breathing.After successful restart the ventilation will be automatically resumed and continued with the latest settings.The device reacted as specified.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: 22554483
• Report Number: 9611500-2025-00394
• Device Sequence Number: 9700605
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)161111(93)8417400-14
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 07/21/2025

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: 06/25/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown