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	06/16/2026
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.Thus, dräger is unable to perform an investigation, the reported shut-down can neither be confirmed nor denied.The most likely explanation for a shut-down would be loss of energy supply.Under consideration that this postulation is correct, an occurrence under single-fault condition is unlikely since the device is equipped with an internal battery to cover mains power losses for at least 30 minutes (with a fully charged battery in good condition).But if - for example - the device was put into operation with a completely worn internal battery, a power supply malfunction or a cut-off of mains supply caused by infrastructure issues may have ended-up in a shut-down.Finally, the issue may also have been related to use error - e.G.If the device was not connected to mains power and operated until the battery was depleted.A reliable conclusion is not possible due to lack of information.It is recommended to have the device checked by authorized personnel and to have it repaired if necessary.
Event or Problem Description
Dräger received an ufr in which it was stated that the hospital staff noticed during a round to the ward that the ventilator had shut down.As per report, the device was immediately replaced which prevented from health consequences for the patient.

• 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: 25663733
• Report Number: 9611500-2026-00332
• Device Sequence Number: 10406922
• Product Code: CBK
• UDI-Device Identifier: 04048675251422
• UDI-Public: (01)04048675251422(11)151001(93)8417800-23
• 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): 06/30/2026

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: 06/22/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2015
• 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