MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V800; ANAESTHESIA AND PULMONARY VENTILATION SUPPORT INSTRUMENT

Model Number	8422500
Medical Device Problem Codes	Decrease in Pressure (1490); Failure to Deliver (2338); Improper Flow or Infusion (2954); Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at around 06:18, the waveform suddenly disappeared.The device was replaced.The user attached a test lung to the affected device and attempted ventilation, but ventilation could not be achieved.When we collected the event log, negative pressure was observed.No patient health consequences have been reported.
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 at around 06:18, the waveform suddenly disappeared.The device was replaced.The user attached a test lung to the affected device and attempted ventilation, but ventilation could not be achieved.When me collected the event log, negative pressure was observed.No patient health consequences have been reported.
Additional Manufacturer Narrative
The log file indicates that the negative airway pressure was caused by an application issue which led to the stop of flow delivery during the reported time.The device reacted like specified and posted accompanying alarm messages because of an application issue.As a result of the negative airway pressure the flow delivery stopped and the safety valve opened to ambient for allowing spontaneous breathing.A device malfunction could not confirmed by log file analysis.The situation could also not reproduced during onsite investigation.It was reported that a closed suction was not used.The breathing circuit system was replaced and the device was tested per manufacturer specification without any issue.As a safety feature of the system, the safety software analyses and verifies proper function of the device.If the safety software detects a negative airway pressure an accompanying alarm message would posted, the flow delivery would stopped and the safety valve would open to ambient for allowing spontaneous breathing.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.

• 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 ; 4518822868
• MDR Report Key: 24543336
• Report Number: 9611500-2026-00097
• Device Sequence Number: 5724766
• Product Code: CBK
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)250321(93)8422500-08
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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