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	06/22/2025
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 had failed during operation and alarmed a device failure.There was 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 the evita v800 performed a synchronised restart of the ventilation unit and the display unit on (b)(6) 2025 at 00:19 am.The restart was triggered as a specified response to a detected deviation in the circuit board of the flow and pressure measurement module.The device alarmed for the device failure and "pressure measurement impaired" as intended.The faulty circuit board has already been replaced by dräger service.The device was tested and confirmed to be operating as per manufacturer's specifications.As a safety function of the device, the software analyses and checks the proper functioning of the device.If a fault is detected in the flow and pressure measurement module, the device restarts to rectify the problem and emits an audible alarm to warn the user.In the event of a complete ventilation failure, the emergency breathing valve opens to the environment to allow spontaneous breathing.Accompanying alarms are activated to inform the user of the problem.However, manual ventilation with an alternative device may be deemed necessary.The device responded as specified to a detected deviation and issued appropriate alarms to inform the user of the event.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 had failed during operation and alarmed a device failure.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: 22505514
• Report Number: 9611500-2025-00382
• Device Sequence Number: 18457704
• Product Code: CBK
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)210202(93)8422500-04
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/29/2025

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: 06/30/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• 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.; NA.
• Patient Sex: Unknown