MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SAVINA; VENTILATOR, INTENSIVE CARE

Model Number	8414450
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
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: a reboot is the specified device behavior to overcome interrupts in the processing of sw routines that can't be rectified by other means.To set all processes back to a controlled state, the device briefly powers off and back on, the breathing system will be opened to ambient to allow spontaneous breathing.The user is alerted by means of a corresponding alarm.Under consideration that the reboot can remedy the error condition (as it was the case in the particular event, obviously), the device will resume ventilation with previous settings after approx.12 seconds.The device responds to various conditions with a reboot, and these do not only includes technical issues but also use error, infrastructure issue and others.For the particular case is not known which deviation triggered the reboot.It is thus recommended to have the device checked by trained service personnel and to have it repaired if necessary.
Event or Problem Description
Dräger received an ufr in which it was reported that the device performed a reboot during a running ventilation episode whereupon the users decided to replace the device in a controlled maneuver.As per report, the vital signs of the patient remained stable throughout the course of event; no health consequences have occurred, finally.

• Brand Name: SAVINA
• 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 ; 4518822868
• MDR Report Key: 24827245
• Report Number: 9611500-2026-00149
• Device Sequence Number: 13066991
• Product Code: CBK
• UDI-Device Identifier: 04048675016403
• UDI-Public: (01)04048675016403(11)160224(17)190101(93)8414450-41
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K003068
• 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): 04/09/2026

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: 8414450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2016
• 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
• Patient Sex: Unknown