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

Model Number ASNE-0056

Device Problems Gas Output Problem (1266); Use of Device Problem (1670); Failure to Deliver (2338); No Apparent Adverse Event (3189); Intermittent Communication Failure (4038)

Patient Problem Insufficient Information (4580)

Event Date 01/14/2021

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 while in use on a patient, the device displayed the alarm ¿ device failure¿ during the ventilation.No patient consequences have been reported.

Manufacturer Narrative

The investigation has been performed based on the available description of event and the provided log file from the affected device.Other than reported the affected device serial number was evita v800 (b)(6) 2021.The analyses of the provided log file revealed that the safety software detected a high negative expiratory pressure of -60 mbar on (b)(6) 2021.Consequently, the alarm message "device failure" was posted by the evita 800 and the ventilation unit performed a pressure release.As per log file the ventilation has continued after three seconds.A short-term pressure release can be caused by a closed suction, brief kinking of the ventilation hose system or defensive behavior of the patient towards mechanical ventilation and is not related to a technical malfunction of the device.Based on the analysis, there was no indication that an internal device error has led to the described behavior.The pressure and flow measurement modul was tested without any deviation.As a safety feature of the system, the safety software analyses and verifies proper function of the device.If the safety software detects an internal failure concerning the pressure measurement system, the emergency-breathing valve would open to ambient allowing for spontaneous breathing.Audible alarms would be posted to inform the user about the problem.However, manual ventilation with an alternate device may be considered necessary.The device reacted as specified to a significant difference in expiratory and inspiratory pressure with accompanying alarm message and a pressure release of the pneumatic system.The investigation did not reveal any new or additional risk that had not already been taken into account in the safety concept of the device.There were no patient consequences reported.Based on the final investigation results this case is no longer considered to be reportable.

Event Description

It was reported that while in use on a patient, the device displayed the alarm ¿ device failure¿ during the ventilation.No patient consequences have been reported.

• Brand Name: EVITA V800
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11632847
• MDR Text Key: 246237336
• Report Number: 9611500-2021-00146
• 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: 05/19/2021

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: No Information
• Device Model Number: ASNE-0056
• Device Catalogue Number: 8422500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1