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); Failure to Deliver (2338); Reset Problem (3019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device restarted when it was connected to a patient.The device continued to work on the patient until it was replaced.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
The log file of the affected device was analysed regarding the reported event.Based on the log file analysis the reported event could be confirmed.The device performed an unexpected restart of the ventilation unit with accompanying visual and auditory alarm on the 5th of december 2023.The restart was triggered by the safety software as a specified reaction on a detected time-out in the software task processing.As a safety feature of the system, the safety software analyses and verifies proper function of the device.In case of a detected deviation regarding operation of the ventilation unit, the safety software triggers a synchronized restart of the ventilation unit and the ecd in order to reset the system to a specified state.During restart sequence the ventilation is temporarily interrupted, and the safety valve is opened to ambient allowing the patient for spontaneous breathing.The deviation will be indicated by activated auxiliary auditory alarm.The restart sequence of the ventilation unit takes up to a maximum of 8 seconds until evita v600 automatically resumes the ventilation with the latest settings.The restart sequence of the ecd may take up to a maximum of 1 minute.In the meantime, the user can observe the already resumed ventilation and safety-relevant parameters such as fio2 concentration, minute volume and airway pressure in the oled-display of the ventilation unit.Finally, the alarm message "ventilation unit restarted" will be prompted on the screen with accompanying auditory alarm and the auxiliary auditory alarm ceases automatically.The ventilator reacted as specified on a detected time-out in the software task processing and triggered a synchronized restart of the ventilation unit and the ecd.The user was notified about the situation by posted auditory and visual alarm.Dräger became aware about other complaints with respect to the same error pattern.A deeper analysis of the error pattern was performed.A fsca has been published.
Event or Problem Description
It was reported that the device restarted when it was connected to a patient.The device continued to work on the patient until it was replaced.There were no health consequences for the patient 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: 19564685
• Report Number: 9611500-2024-00257
• Device Sequence Number: 17677436
• Product Code: CBK
• UDI-Device Identifier: 04048675548744
• UDI-Public: (01)04048675548744(11)200417(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: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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 Model Number: 8422300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2517967-4/16/2021-001-C
• Patient Sequence Number: 1
• Patient Sex: Unknown