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

Model Number	8414000
Medical Device Problem Codes	Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility report (ufr) was the only source of information; the hospital did not involve the local dräger s&s organization into any follow-up measures and did not provide additional details upon request.A case-specific evaluation is not possible.The following can be derived from the ufr: the device reportedly performed reboots intermittently.A reboot is the specified behavior to overcome interrupts in the processing of sw routines that cannot be rectified by other means.The device will briefly power off and back on and continue ventilation with the latest settings if the reboot remedies the error condition.A typical reboot lasts approx.12 seconds; the device opens the airway system to ambient during this time to allow spontaneous breathing.The exact root cause cannot be derived from the information supplied with the ufr.However, based on experience, the most likely explanation would be that the device was put into operation with a worn internal battery and that a second fault condition came into effect.An example for such condition would be internal overheating.When the temperature inside the device is too high, the sw switches off the power supply to allow it to cool down, operation will be continued on battery then.But if the internal battery is not able to supply the device with energy for a certain period of time, a reboot will be triggered, and the device will resume operation on mains supply.But when the temperature inside the device is still high after the short sequence of battery operation, the power supply will be switched off again, and reboots in a row will occur.If the postulation is correct, the reported event must be attributed to lack of preventive maintenance and to failure to follow the instructions of the manufacturer; the ifu "emphasizes" that availability of the internal battery shall be checked prior to each new ventilation episode.The aforementioned is only one example for an imaginable scenario; other explanations may apply as well; a further differentiation is not possible due to the limited information.It is recommended to the hospital to have the device checked by trained service personnel.
Event or Problem Description
It was reported that the device performed intermittent reboots during a running ventilation episode.The users reportedly replaced the device in a controlled maneuver; health consequences for the patient did not occur.

• 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: 22326772
• Report Number: 9611500-2025-00330
• Device Sequence Number: 8289004
• Product Code: CBK
• UDI-Device Identifier: 04048675407881
• UDI-Public: (01)04048675407881(11)220816(93)8414000-39
• 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): 06/25/2025

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: 06/13/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2022
• 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