MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SAVINA 300; VENTILATOR, INTENSIVE CARE

Model Number	8417801
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
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 can thus not perform an investigation.The complaint cannot be fully understood - it is not known if just the display blanked out or if the device fully stopped operation due to e.G.Power loss.There was no serial number information transmitted; age of the device and state of preventive maintenance and repairs is not known to dräger.There's no conclusion possible if component malfunction, infrastructure issues, lack of preventive maintenance, use error or a combination of multiple factors caused or contributed to the event.It is recommended to have the unit checked by authorized personnel and to have it repaired if necessary.
Event or Problem Description
Dräger received an ufr filed against an intensive care ventilator simply stating: "black screen during use.Action: repair." there was no detail in the report which would reasonably suggest that patient consequences may have occurred.

• Brand Name: SAVINA 300
• 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: 24827241
• Report Number: 9611500-2026-00148
• Device Sequence Number: 18447154
• Product Code: CBK
• UDI-Device Identifier: 04048675411628
• UDI-Public: (01)04048675411628
• 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: 8417801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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