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

Catalog Number 8422300

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

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

Event Date 12/26/2022

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 the device shutted down with unknown reason while using on patient.No patient injury has been reported.

Event Description

It was reported that the device shutted down with unknown reason while using on patient.No patient injury has been reported.

Manufacturer Narrative

The investigation was based on the reported event, logfile analysis and onsite examination on behalf dräger service support of the affected evita v600 with product serial no.(b)(6).Dräger service support identified a deviation in the m48 board.Pcb assembly and usd cards were requested from the manufacturer in lübeck for further investigation.The investigation results could also confirmed the reported event.The complaint investigation incl.Logfile analysis confirmed an unexpected, synchronized restart of the ventilation unit and the display unit (ecd) due to an access issue in the software task processing caused by a software glitch in the operating system at the reported time.The ventilator has alerted the situation as intended and resumed ventilation after restarting in the last settings.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 display unit (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).Single restart sequence of the ventilation unit takes up to 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 device behaved and alarmed as specified due to a runtime error.The results of this complaint investigation have not identified any new or additional risks that are not already addressed in the product risk management file.

• Brand Name: EVITA V600
• Type of Device: 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
• MDR Report Key: 16240009
• MDR Text Key: 308645328
• Report Number: 9611500-2023-00025
• Device Sequence Number: 1
• Product Code: QOV
• UDI-Device Identifier: 04048675548744
• UDI-Public: (01)04048675548744(11)211213(93)8422300-05
• Combination Product (y/n): N
• PMA/PMN Number: EUA200143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 8422300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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