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	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tthe user facility did not involve the local dräger s&s organization into any follow-up measures and did not provide further details which would enable a case-specific evaluation.Hence, the reported shutdown can neither be confirmed nor denied.Under consideration that the reported observation is correct, the most likely explanation for the shut-down would be a loss of electrical energy supply.The device is equipped with an internal battery to cover mains power losses so the failure scenario includes a failure to run on internal battery.The simpliest explanation would be that the device was not connected to mains power at the time of event and that the device ran on battery until the latter was depleted.An unexpected shut-down after mains power loss may have occurred when the internal battery was overaged already, depleted at the time of event or when the specific error condition did not allow to continue operation on battery supply.Finally, the reported observation of a black screen and (temporary) stop of ventilation would also apply to a situation in which the device performs a reboot.A reboot is the specified behavior to overcome significant deviations in the processing of sw routines; ventilation would be continued after a successful completion of the reboot sequence.The device will post an acoustical alarm for both situations of shutdown or reboot - in case of complete shutdown the alarm will be annouced by the buzzer of the power supply which is buffered by an independent power source.Further conclusions can't be made due to lack of information; the issue may have been related to infrastructure issues, technical malfunctions, use errors or lack of maintenance or a combination of multiple factors.The involved device is 13 years old and not under a service contract, status of preventive maintenance and repairs is unknown.It is recommended to have the device checked by trained service personnel.
Event or Problem Description
It was reported that the device suddenly shut down during use.As per report, the users bridged ventilation support with a manual resuscitator (ambu bag) until a replacement device was made available.The 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: 19653088
• Report Number: 9611500-2024-00275
• Device Sequence Number: 6745512
• Product Code: CBK
• UDI-Device Identifier: 04048675016403
• UDI-Public: (01)04048675016403(11)110121(93)8414450-29
• 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): 07/02/2024

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: 06/17/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2011
• 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