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	11/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screen of the device suddenly went black during a running ventilation episode.As per report, the users replaced the device in a controlled maneuver, no patient consequences were resulting from the event.
Additional Manufacturer Narrative
The user facility did not involve the local dräger s&s organization into any follow-up measures, and dräger was unable to obtain additional details.From the description of event cannot be derived if just the display went black or if the device performed a reboot respectively had shut down completely.If just the display went black the ventilation will be continued but interaction with the device may be impaired.A reboot or shut-down will be accompanied by a corresponding alarm.Further conclusions cannot be derived from the ufr.The device was in operation for ten years now; state of preventive maintenance and repairs is unknown to dräger.The reported observation may have been related to component failure (e.G.Display malfunction or power supply error) but lack of preventive maintenance (device put into operation with a worn/depleted internal battery), use error or infrastructure issues may have contributed to the event.It is recommended to the hospital to have the device checked by trained service personnel.

• 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: 20900014
• Report Number: 9611500-2024-00556
• Device Sequence Number: 12013385
• Product Code: CBK
• UDI-Device Identifier: 04048675016403
• UDI-Public: (01)04048675016403(11)140925(93)8414450-38
• 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): 12/11/2024

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: 11/26/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2014
• 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