MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SAVINA 300; VENTILATORS, 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	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Dräger received an ufr with the following description: "the patient was using the ventilator when the display screen suddenly went black.Immediately reported to the device department for repair, and replaced with another ventilator." there was no detail in the report which would reasonably suggest that health consequences for the patient may have occurred.
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.A case-specific evaluation is not possible.The nature of the fault remains unknown - it cannot be derived from the available information if just the screen turned black, if the device performed a reboot or if it shut itself down completely.A reboot as well as a complete shut-down will trigger an acoustical alarm via the buzzer of the power supply which is buffered by an independent power source.The device was in operation for five years; it is not known if preventive maintenance and repairs were provided according to the recommendations of the manufacturer.Further conclusions can't be derived from the ufr due to lack of information.The reported issue is not necessarily related to suddenly occurring component malfunction - the scenario of complete power loss due to a combination of infrastructure issue (mains power interrupt) and use error (putting the device into use with a worn internal back-up battery) would fit to the reported event, for example.It is recommended to the hospital to have the device checked by authorized personnel and to have it repaired if necessary.

• Brand Name: SAVINA 300
• Common Device Name: VENTILATORS, 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: 25481654
• Report Number: 9611500-2026-00288
• Device Sequence Number: 10322806
• Product Code: CBK
• UDI-Device Identifier: 04048675251422
• UDI-Public: (01)04048675251422(11)210113(17)231101(93)8417800-44
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180779
• 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): 06/12/2026

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: 06/04/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2021
• 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