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

Model Number	8417400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported in a user facility report to national authority that during use on a patient the monitor for pulse oximetry alarmed and a changed skin color was noticed but the ventilator failed to trigger a corresponding alarm.
Additional Manufacturer Narrative
The ufr was the only source of information - the provided information is misleading and could not be clarified even on request.This mdr was filed in abandon of caution.The hospital did not provide a clear description of the event or any follow-up measures - also patient's state during or after the event remains unknown.Dräger suspects that the user/hospital complains/reported a critical patient situation (asphyxia - identified by change of patient¿s skin color) which was not indicated/alarmed by the ventilator itself - but on a separate patient monitor using pulse oximetry, which generated according spo2 alarm (unknown type and manufacturer of patient monitor).This is based on the aspect that the ventilator itself is not capable to measure spo2.It must be further concluded that no stop of ventilation was reported.Dräger is not able to further investigate the reported problem due to the very limited information available - but clearly emphasizes that application and setting of the ventilator has to be done according to patient needs and that especially the alarm settings must be made for the individual patient situation.Finally, the few available information does not indicate a device malfunction - an insufficient ventilation situation may also be related to patient physiology - which must be monitored by the user using appropriate separate monitoring.It is not clear what type of ventilation alarm the user was expecting.Finally an exact evaluation of the reported event / observed problem is not possible due to insufficient information.

• Brand Name: INFINITY ACUTE CARE 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: 23597866
• Report Number: 9611500-2025-00635
• Device Sequence Number: 10380646
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)230224(17)240111(93)8417400-20
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2023
• 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