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	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dräger received an ufr with the following description: ".The ventilator screen suddenly went blank and ceased functioning".As per report, the patient was connected to another device.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.Dräger derives the following: the reported shut-down can neither be confirmed nor denied without access to the device or to a log file covering the period in question.Under consideration that indeed a shut-down has occurred, the most likely triggering condition would be a complete loss of energy.The primary energy source for the device is mains supply but the unit is also equipped with an internal battery to cover mains power losses for at least a period of time.Following from that, a complete shut-down is unlikely to occur in single-fault conditions.Imaginable scenarios would be that the user has ignored the battery depletion warnings after mains power got lost for whatever reason or that the device was put into operation with a completely worn internal battery.A complete shut-down is always accompanied by an acoustical alarm generated by a buzzer which is buffered by an independent power source (gold cap capacitor).Finally, it is not clear if indeed a shut-down has occurred or not - the user may also have perceived a reboot of the device as a shut-down since the display blanks out for some seconds during a reboot.The device is almost nine years old; the status of preventive maintenance and repairs is unknown.It is thus recommended to the hospital to have the device checked by authorized service personnel and to have it repaired if necessary.

• 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: 23603253
• Report Number: 9611500-2025-00638
• Device Sequence Number: 15813556
• Product Code: CBK
• UDI-Device Identifier: 04048675016403
• UDI-Public: (01)04048675016403(11)141020(93)8414450-38
• 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): 11/20/2025

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: 11/11/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2014
• 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