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	Low Oxygen Saturation (2477)
Date of Event	08/04/2025
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.Without access to the device or to the log file that covers the date of event, it is not possible for dräger to confirm or deny the reported event.The following can be concluded: the ventilator box has a toggle switch with mechanical positions for on and off - the wording in the ufr would suggest that this toggle switch was found in the off position during the course of event.To access this toggle switch, a flap at the left side of the ventilator box has to be opened.It can be excluded that the toggle switch is set to off by other interaction than intended user input.The concerned device is 9.5 years old, status of repairs and preventive maintenance is not known to dräger.It is recommended to the hospital to have the device checked by trained service personnel.
Event or Problem Description
Dräger received an ufr with the following statement: "on (b)(6) 2025, the responsible nurse observed the patient's oxygen saturation at 85%.Upon immediate inspection, it was discovered that the respiratory therapy system, which had been in use for 12 hours, had automatically shut down, with the power switch in the off position.After resetting the power switch, the ventilator backed to normal use, and the child's oxygen saturation subsequently increased to 96%." no health consequences for the patient have resulted from the event.

• Brand Name: INFINITY ACUTE CARE WORKSTATION NC
• Common Device Name: VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA

4518822868

• MDR Report Key: 22892375
• Report Number: 9611500-2025-00472
• Device Sequence Number: 14903538
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)160209(17)161106(93)8417400-14
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2025

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: 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: 08/08/2025
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2016
• 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