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	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Drager received an ufr in which it was stated that the device posted an alarm during use indicating a failure in the ambient pressure measurement and shut itself off in the following.There was no detail in the report which would reasonably suggest that health consequences for the patient may have resulted from the event.
Additional Manufacturer Narrative
The ufr was the only information for this case; the hospital did not involve the local drager s&s organization into any follow-up measures.The contact person named in the ufr could not provide further information.Drager derives the following: the device is equipped with a pressure sensor for measurement of the atmospheric pressure; the readings are used for calibration of other measurement functions such as airway pressure, fio2 or gas flow.The ifu clearly describes the device behavior and the required operator response when ambient pressure measurement fails - the accuracy of the readings for the aforementioned values may be impaired, and if the incorrect values are tolerable and the limit for the "airway pressure high" alarm is set accordingly, ventilation can be continued.In any case, the device will not respond with a shut-down upon a failure of the ambient pressure measurement.Either there was a second fault condition that triggered the shutdown or the user's report is incorrect in this detail this conflict cannot be removed due to lack of relevant information.A reliable conclusion in regard to the root cause for the reported observation could not be found.It is recommended to the hospital to have the device checked and - if necessary - repaired by trained service personnel.

• Brand Name: SAVINA
• Common Device Name: VENTILATOR, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA

4518822868

• MDR Report Key: 22993494
• Report Number: 9611500-2025-00505
• Device Sequence Number: 8833622
• Product Code: CBK
• UDI-Device Identifier: 04048675407881
• UDI-Public: (01)04048675407881(11)230119(93)8414000-39
• 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): 09/08/2025

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: 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: 08/28/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2023
• 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