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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ufr was the only information for this case; the hospital did not involve the local dräger s&s organization into any follow-up measures.The contact person named in the ufr could not provide further information.Dräger derives the following: the available information does neither allow to understand what exactly has happened nor enables an evaluation; this report is filed in abundance of caution.It can be concluded that the issue in general does not incorporate a previously unidentified or falsely assessed risk since the device detected the deviation and posted a corresponding alarm.The nature of the issue however remains unknown.The triggering condition may include component failures as well as infrastructure problems (e.G.Gas supply insufficient), lack of preventive maintenance (expiratory valve worn) and even issues with peripheral equipment (the effects of a significant leak in the patient circuit may be perceived as a ventilation problem).A differentiation is not possible due to lack of information.All types of alarms, potential root causes and dedicated remedies are listed in the ifu.It is recommended to the hospital to have the device inspected by authorized service personnel and to have it repaired if necessary.
Event or Problem Description
Dräger received an ufr in which the following was stated: "during normal operation of the ventilator in the anesthesiology department, the device suddenly alarmed and became inoperable.A backup device was deployed as replacement." there was no detail in the report which would reasonably suggest that the event may have led to consequences for the patient.

• 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: 23603251
• Report Number: 9611500-2025-00637
• Device Sequence Number: 9444290
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)170906(93)8417400-16
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2017
• 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