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

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Reset Problem (3019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that the evita v600 performed several warm starts during ventilation.No patient consequences were reported.

Event Description

It was reported that the evita v600 performed several warm starts during ventilation.No patient consequences were reported.

Manufacturer Narrative

The log file of the affected device was provided and analyzed.For the day of the event on 16th of march 2021, no restarts are evident in the logbook.Based on the log file analysis, it was confirmed that the unit performed unexpected ventilator restarts between 12th and 13th of march 2021.These restarts were 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 analyzes 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 safety valve is opened to ambient allowing the patient for spontaneous breathing.The deviation will be indicated by activated auxiliary auditory alarm (piezo speaker of the ventilation unit).The restart sequence of the ventilation unit takes approx.8 seconds until the ventilation is automatically resumed with the latest settings.The restart sequence of the ecd may takes approx.1 minute.In the meantime, the user can observe the already resumed ventilation and safety-relevant parameters on 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 device 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 an auditory and visual alarm.There were no patient consequences reported.The restarts occurred due to an error in the software.Based on the logged data a hardware failure was assessed rather unlikely.Testing the device according to the manufacturer¿s test specification is recommended prior to further use.Dräger became aware about other complaints with respect to the same error pattern.A deeper analysis of the error pattern was initiated.A fsca has been published.

• Brand Name: EVITA V600
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11633123
• MDR Text Key: 249279793
• Report Number: 9611500-2021-00147
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: EUA 200143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1