MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V600; VENTILATORS, INTENSIVE CARE

Model Number	8422300
Medical Device Problem Codes	Gas Output Problem (1266); Decrease in Pressure (1490); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device while operated in o2 therapy mode alerted loudly and shrilly several times within an hour, then shut down and rebooted.There were no patient health consequences reported.
Additional Manufacturer Narrative
The affected device was examined onsite by dräger service and the log file was made available for further investigation.The analysis of the log file revealed that the ventilation unit had performed restarts on the reported date of event.In the course of the investigation, the pba m48.3 and the micro-sd cards were requested for a hardware analysis in addition.Based on the log file analysis, it could be verified, that the ventilation unit performed restarts on the reported date of event.Contrary to what was reported, the restarts occurred in o2 therapy mode but also in pc-bipap mode.After a successful restart, the alarm message ¿ventilation unit restarted¿ was displayed on the screen and ventilation was then continued.The restart was triggered by a temporary failure of the pba m48.3.The pba m48.3 was replaced by dräger service and the device was tested and confirmed to be operating as per manufacturer´s specification.The hardware analysis of the requested and returned parts did not reveal any permanent malfunction.For safety reasons, the software of the ventilator continuously analyses and verifies the correct function of the device.In the event that the safety software of the ventilation unit requests a warm start, the emergency valve is opened against the environment to allow the patient to breathe spontaneously.After a successful restart of the ventilation unit, the alarm message ¿ventilation unit restarted¿ is issued with an accompanying acoustic alarm tone sequence.The device behaved as specified and displayed the corresponding alarm message on the screen to inform the user of the problem.Based on the investigation result, the case was re-assessed and considered to be reportable.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: EVITA V600
• 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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 23629706
• Report Number: 9611500-2025-00643
• Device Sequence Number: 10291412
• Product Code: CBK
• UDI-Device Identifier: 04048675548744
• UDI-Public: (01)04048675548744(11)200522(93)8422300-04
• 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
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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: 8422300
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2020
• 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