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	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As a side note, it was mentioned in the ufr that the device was restarted after the event which was successfully possible and that a pre-use check was passed without deviations.This can be the reason why the user facility did not involve the local dräger s&s organization into any follow-up measures and was not able to provide additional details upon request.A case-specific evaluation cannot be done due to missing log file or other relevant details.In fact, it is not possible to bring all reported aspects (stop of ventilation, no alarm, unresponsive user interface, successful reboot afterwards) together to a clear picture.A complete shut-down (loss of energy) can be excluded as an explanation since it is always accompanied by an acoustical alarm, and the user would certainly not describe a black display as "unresponsive touch screen"; it is further unlikely that the underlying error condition can be removed by rebooting the device.An unresponsive touch screen will not trigger an alarm but will not have an influence on the ventilation performance while a stop of ventilation will always be announced by a corresponding alarm.Further conclusions cannot be derived from the ufr, the root cause for the reported observation cannot be found.It is recommended to have the device checked by trained service personnel.
Event or Problem Description
It was reported that the users became aware from an alarm issued by the patient monitoring system that the ventilator was not working.As per report, the user interface of the device was found unresponsive and thus, it was decided to connect the patient to another device instead.It was stated that ther event did not lead to consequences for the patient.

• 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 21176648
• Report Number: 9611500-2025-00040
• Device Sequence Number: 17209105
• Product Code: CBK
• UDI-Device Identifier: 04048675407881
• UDI-Public: (01)04048675407881(11)201214(93)8414000-38
• Combination Product (Y/N): N
• 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): 01/17/2025

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: 01/03/2025
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2020
• 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