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

Model Number	8414000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
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 is unable to determine the system effect of the malfunction from the few available facts.It cannot be excluded that the device posted an alarm for e.G.Malfunction of the flow sensor which affects monitoring only and that the operators thereupon decided to replace the device.On the other hand, it is not possible to deny that the device stopped the ventilation or shut itself off - the user's report is too unspecific in that point.Hence, this report is filed in abundance of caution.The device is more than 8 years old, state of preventive maintenance and repairs is not known to dräger.Dräger recommends to the hospital to have the workstation checked by authorized personnel and to have it repaired if necessary.
Event or Problem Description
Dräger received an ufr stating the following: "during the patient's use of the equipment, it suddenly malfunctioned and became inoperable.The device was immediately replaced." there was no detail in the report which would reasonably suggest that patient consequences may have occurred.

• 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: 24953998
• Report Number: 9611500-2026-00166
• Device Sequence Number: 12072544
• Product Code: CBK
• UDI-Device Identifier: 04048675407881
• UDI-Public: (01)04048675407881(11)170130(93)8414000-36
• 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): 04/22/2026

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: 8414000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2017
• 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