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

Catalog Number	8422300
Medical Device Problem Codes	Gas Output Problem (1266); Decrease in Pressure (1490); Reset Problem (3019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The log file of the affected device was provided and analysed for the investigation.Based on the log file analysis, the reported event could be confirmed: on the 27th of december 2023 at 01:59 system time, the device performed an unexpected, synchronized restart of the ventilator and the display unit.The root cause was determined to be an access problem in the software task processing.The safety concept of the device provides that the software monitors the function of the device with regard to correct operation.If a deviation is detected during operation of the ventilator, the safety software triggers a synchronized restart of the ventilator and the display unit to bring the system into a specified state.During the restart sequence, ventilation is temporarily interrupted, and the safety valve is opened to ambient, allowing the patient to breathe spontaneously.The restart is indicated by an activated auxiliary acoustic alarm.A single ventilator restart sequence lasts up to 8 seconds until the device automatically resumes ventilation with the last settings.The display unit restart sequence can take up to a maximum of 1 minute.In the meantime, the user can observe the ventilation already resumed and safety-relevant parameters such as fio2 concentration, minute volume and airway pressure on the oled display of the ventilator.Finally, the alarm message "ventilation unit restarted" with accompanying acoustic alarm is displayed on the display and the additional acoustic alarm goes off automatically.In the present case, the ventilator has reacted as specified to the detected deviation and resumed ventilation with the last settings after the restart.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 evita v600 restarted automatically during ventilation of the patient.The device emitted an audible alarm.It was reported that an internal communication error was displayed during start-up.Ventilation was then continued with the last settings.No health consequences for the patient were reported.

• 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 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18541051
• Report Number: 9611500-2024-00021
• Device Sequence Number: 12707558
• Product Code: CBK
• UDI-Device Identifier: 04048675548744
• UDI-Public: (01)04048675548744(11)201020(93)8422300-04
• Combination Product (Y/N): N
• 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): 01/19/2024

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 Catalogue Number: 8422300
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2020
• 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