MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V800; VENTILATORS, INTENSIVE CARE

Model Number	8422500
Medical Device Problem Codes	Gas Output Problem (1266); Decrease in Pressure (1490); Failure to Sense (1559); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
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 device switched off without any notification during use.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
The log file of the affected device was analysed regarding the reported event.The analysis of the log file could confirm that evita v800 performed a synchronized restart of the ventilation unit and display unit on (b)(6) 2025 around 12:36 pm.The restart was caused in specified reaction on a detected deviation in the circuit board of the flow and pressure measurement module.The event was accompanied by the intended alarm messages "ventilation unit restarted".The faulty circuit board, as well as both data cables and the power cable of the flow and pressure measurement module were already replaced by the dräger service.The device was tested and confirmed to be operating as per manufacturer's specifications.As a safety feature of the device, the software analyses and verifies proper function of the device.In case of a detected failure concerning the flow and pressure measurement module the device would perform a restart to mitigate the issue and post an audible alarm in order to alert the user.In case of a complete loss of function of the ventilation, the emergency-breathing valve would open to ambient allowing for spontaneous breathing.Accompanying alarms will be activated in order to inform the user about the problem.However, manual ventilation with an alternate device may be considered necessary.The device reacted like specified to a detected deviation and posted appropriate alarm messages to inform the user about the problem.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that the device switched off without any notification during use.There were no health consequences for the patient reported.

• Brand Name: EVITA V800
• Common Device Name: VENTILATORS, 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: 22528545
• Report Number: 9611500-2025-00387
• Device Sequence Number: 7410640
• Product Code: CBK
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)201214(93)8422500-04
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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: 8422500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2020
• 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