MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V800; VENTILATORS, INTENSIVE CARE

Catalog Number 8422500

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)

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

Event Date 04/28/2022

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 after 3 minutes of ventilation a "reboot after system error" occurred.No patient health consequences have been reported.

Manufacturer Narrative

The investigation was based on the reported event and the logfile analysis of the affected evita v800 with serial number (b)(6).Based on the log file, the reported event could be confirmed.The first reboot of the device occurred on (b)(6) 2022, 16:49 system time.The restart occurred shortly after the device was turned on, with the user switching back and forth between standby and ventilation three times.Data logging stopped unexpectedly at 4:50 pm system time, and the next restart was logged at 7:43 am system time on april 28, 2022, after the device was turned back on.Thereafter, two more restarts occurred within a short period of time without patient involvement, which were alerted as specified, with accompanying visual and audible alarms.On site, a dräger service technician replaced the usd card and the pba m48.3 board and sent them to the manufacturer's site in lübeck for detailed investigation.Analysis of the pba m48.3 revealed a hardware fault in the component, which was identified as the root cause of the restarts.The usd cards provided did not show any deviation.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 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 (piezo speaker of the ventilation unit).The restart sequence of the ventilation unit takes up to a maximum of 8 seconds until evita v800 automatically resumes the ventilation with the latest settings.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 and performed a reboot to set the micro processing system to a specified state and posted the alarm message "ventilation unit restarted" to inform the user about the situation.However due to an existing hardware malfunction the reboot could not solve the issue sustainable.Field quality data are monitored and assessed by the responsible product quality board.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 Description

It was reported, that after 3 minutes of ventilation a "reboot after system error" occurred.No patient health consequences have been reported.

• Brand Name: EVITA V800
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 14389362
• MDR Text Key: 297359752
• Report Number: 9611500-2022-00115
• Device Sequence Number: 1
• Product Code: QOV
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8422500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1