MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACUTE CARE WORKSTATION NC; VENTILATOR, INTENSIVE CARE

Model Number	8415000
Medical Device Problem Codes	Use of Device Problem (1670); Pressure Problem (3012); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Upper Respiratory Tract Injury (4599)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to dräger that the ventilator suddenly posted alarms during use indicating a disturbed ventilation.As per report, the users observed a small amount of blood in the et tube, and the patient experienced a desaturation.The report does not contain a clear indication for the potential presence of a device malfunction, and the user did not allege one.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up/final report.
Event or Problem Description
It was reported to dräger that the ventilator suddenly posted alarms during use indicating a disturbed ventilation.As per report, the users observed a small amount of blood in the et tube, and the patient experienced a desaturation.The report does not contain a clear indication for the potential presence of a device malfunction, and the user did not allege one.
Additional Manufacturer Narrative
A significant desaturation was reported.The users observed blood in the et tube - a causal connection to the ventilation or to use error cannot be excluded at the time the reporting decision was due.The review of the provided log file and video clip confirmed that the ventilator prompted the alarm messages "disconnection?" and "peep high" caused by an increased expiratory resistance during a test run with a neonatal test lung (on (b)(6) 2026, at 19:11 system time).The logfile also showed that during the reported time, shortly before, while ventilating a patient in pc-simv ventilation mode, the ventilator also prompted several alarms indicating impaired ventilation, such as "airway pressure high", "airway pressure negative (averaged)", and "airway pressure low".The ventilator performed several pneumatic resets for pressure release as specified in reaction to detected high and/or negative airway pressure.As per the log file, no device check and no breathing circuit check were performed prior to therapy.A device malfunction could not be confirmed by log file analysis.Further requested information was not provided.The device reacted as specified to high and negative airway pressure and performed pneumatic releases.Appropriate alarm messages were posted by the cockpit c500.Thus, the situation could have been caused by an issue with the breathing circuit (e.G.Obstruction in the breathing circuit and/or non-calibrated breathing circuit).If not yet done, check the device for proper function according to the manufacturer's test protocol.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.

• Brand Name: INFINITY ACUTE CARE WORKSTATION NC
• Common Device Name: VENTILATOR, INTENSIVE CARE
• 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 ; +49 4518822868
• MDR Report Key: 24673137
• Report Number: 9611500-2026-00121
• Device Sequence Number: 13352159
• Product Code: CBK
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown