MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V300; VENTILATORS, INTENSIVE CARE

Catalog Number 8420400

Device Problems Gas Output Problem (1266); Sensing Intermittently (1558); Tidal Volume Fluctuations (1634)

Patient Problem Cyanosis (1798)

Event Date 04/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported: a patient was ventilated with a niv full-face mask.After a very short time, the patient removed the mask because of missing air flowed through the ventilation tube.The staff reacted immediately and continued ventilation with another device.During the subsequent test, a recurring clacking was audible from the device, but no air flow.In another test, the device worked again without any problems.The device was previously used for several days for intubated ventilation on the same patient.It was noted that the patient turned blue during the event.

Event Description

Please refer to the initial-report.

Manufacturer Narrative

The affected device was analyzed onsite by the dräger service and the logfile was sent to the dräger device experts.Based on the log entries, it could be confirmed that inconsistencies in the expiratory flow measurement were detected on the day of the event.Alarms such as ¿airway pressure low¿, ¿disconnection¿, ¿vt high¿, ¿mv high¿ and ¿airway pressure high¿ were also generated during the event.The alarms ¿disconnection¿, ¿vt high¿ and ¿mv high¿ briefly affect ventilation, e.G.By aborting the current breathing cycle.It cannot be excluded that the alarms were generated in part due to a deviation in the expiratory flow measurement.A faulty flow sensor cable was identified as the cause in the device analysis.The cable has already been replaced and the device has now passed all tests.The expiratory flow measurement is used to control and monitor the ventilation.In the event of an error, temporarily deviating flow measurement values can impair the ventilation due to their part in the control circuit.This can also lead to the reported ¿clacking¿ sound.If the set alarm limits are exceeded, the device alarms according to the specification.In the instructions for use, the user is encouraged to ventilate the patient in the event of a device malfunction using an independent ventilation device (e.G.With an emergency manual ventilation bag).The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: EVITA V300
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10028223
• MDR Text Key: 189975080
• Report Number: 9611500-2020-00144
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675389354
• UDI-Public: (01)04048675389354(11)160727(17)161231(93)8420400-06
• Combination Product (y/n): N
• PMA/PMN Number: K093633
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8420400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1