MAUDE Adverse Event Report: Drägerwerk AG & Co. KGaA Evita V800; Anaesthesia and pulmonary Ventilation support instrument

Model Number	8422500
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the display of the unit went blank while the device was still ventilating.At a later point the device shut down by itself.No patient injury was reported.
Event or Problem Description
It was reported that the display of the unit went blank while the device was still ventilating.At a later point the device shut down by itself.No patient injury was reported.
Additional Manufacturer Narrative
The investigation was based on the provided information.The log file was not made available for further investigation.It was reported that the display of the device could not be turned on.The customer replaced the circuit board m48 and the microsd cards which could not solve the issue.It was reported that the power board was replaced.It is not known if the replacement of the power board has solved the reported failure.Based on the available information, the root cause for the report failure could not be determined.In case of a complete loss of function of the ventilator, the safety valve automatically opens to ambient allowing the patient for spontaneous breathing.The secondary acoustic alarm system (piezo speaker) of the ventilation unit will be activated in order to alert the user to the situation.This alarm is energized from an independent power source and will be last for at least 2 minutes.The results of the investigation did not reveal any new risks which are not covered by the product risk management.

• Brand Name: Evita V800
• Common Device Name: Anaesthesia and pulmonary Ventilation support instrument
• 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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; +49(451)8822868
• MDR Report Key: 24266646
• Report Number: 9611500-2026-00041
• Device Sequence Number: 21497308
• Product Code: CBK
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)240115(93)8422500-08
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 8422500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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