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

Model Number	8415000
Medical Device Problem Codes	Decrease in Pressure (1490); Inaccurate Delivery (2339); Gas/Air Leak (2946); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/10/2025
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 from the customer that the vn500 device alarmed with 'airway pressure low' whilst in use on a patient.Patient suffered repeated instances of desaturation.The device was exchanged.At the present time, a restriction or a stopp of ventilation cannot be excluded.In case the breathing pressure (incl.Peep) drops to ambient, a deterioration in state of health cannot be excluded for patients with difficult lung/ventilation conditions.
Event or Problem Description
It was reported from the customer that the vn500 device alarmed with 'airway pressure low' whilst in use on a patient.Patient suffered repeated instances of desaturation.The device was exchanged.At the present time, a restriction or a stopp of ventilation cannot be excluded.In case the breathing pressure (incl.Peep) drops to ambient, a deterioration in state of health cannot be excluded for patients with difficult lung/ventilation conditions.
Additional Manufacturer Narrative
It was reported that the patient¿s spo2 saturation temporarily decreased.No serious injury was reported.The affected evita vn500 device was examined onsite by dräger service and tested according to manufacturer specs without deviations.The logfile was send for further analysis to the manufacturer site in lübeck.According to the logfile, the device reacted like specified and posted accompanying alarm messages because of a detected disconnection.No device malfunction or deviation of the pressure measurement system could be detected as result of the investiagations.As a safety feature of the system, the safety software analyses and verifies proper function of the device.In case of a detected disconnection the evita device would post accompanying alarm messages to inform the user about an issue.Based on the results of the investigation, this case is no longer considered reportable in accordance with meddev 2.12 rev.08, as neither a fatality nor a serious injury was caused and this is not expected to happen in the event of a recurrence.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.

• 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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 23401431
• Report Number: 9611500-2025-00603
• Device Sequence Number: 18687015
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)170829(93)8417400-16
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 12/12/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 8415000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2025
• 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.; NA.
• Patient Sex: Unknown