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); No Flow (2991); Reset Problem (3019)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2022

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 monitor of the v-unit suddenly shut down during ventilation and then also rebooted on its own.The user could not safely rule out an additional reboot of the ventilation unit.The affected device alarmed high priority.No patient health consequences have been reported.

Event Description

It was reported that the monitor of the v-unit suddenly shut down during ventilation and then also rebooted on its own.The user could not safely rule out an additional reboot of the ventilation unit.The affected device alarmed high priority.No patient health consequences have been reported.

Manufacturer Narrative

For the investigation of the reported event, the logbook and the requested parts of the affected evita v600 with serial number asnj-0001 were available to the manufacturer for examination.A dräger service technician additionally examined the device on site and could not detect any deviations.Analysis of the submitted log confirmed that the affected device performed an unexpected synchronized restart of the ventilator unit and control panel at the reported time, due to an access problem in the software process flow chain.The restart was alerted as specified, high priority acoustically via activation of the auxiliary acoustic alarm (ventilator unit piezo sound generator).In lübeck, the pba m48.3 circuit board including the red and blue usd cards were then subjected to a functional test and ram memory stress test in ventilation mode using an independent laboratory device.During a 35-day endurance test of the returned pba m48.3 pcb and the two usd cards, no deviation or reboot could be reproduced.For safety, the safety software analyzes and verifies the correct device function.If the safety software detects a deviation of the ventilation unit from the correct device function, it requests a warm start of the ventilation unit and simultaneously of the control unit as a specified reaction.During a warm start, ventilation is temporarily interrupted and the acoustic auxiliary alarm of the ventilation unit sounds.The safety valve is meanwhile open against the environment to allow the patient to breathe spontaneously.After 8 seconds at the latest, evita v600 automatically continues ventilation in unchanged settings.The warm start of the control unit is completed after one minute at the latest.Meanwhile, the user can follow the already resumed ventilation via the oled display of the ventilation unit and read safety-relevant parameters, such as fio2 concentration, minute volume and airway pressure.The warm start is finally indicated by the alarm message "ventilation unit restarted" on the control unit with acoustic alarm tone sequence and the acoustic auxiliary alarm of the ventilation unit is silenced.Complaint investigation confirmed an unexpected synchronized restart of the ventilator unit and control panel due to an access problem in the software process flow chain.The ventilator alerted the condition as intended and resumed ventilation in the last settings after the restart.The exact cause of the identified access problem could not be conclusively determined.The number of similar cases due to the same cause is within the expected range of the respective risk assessment and is therefore accepted.

• 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: 13357350
• MDR Text Key: 286639762
• Report Number: 9611500-2022-00022
• Device Sequence Number: 1
• Product Code: QOV
• 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: 05/13/2022

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: 01/13/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2020
• 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