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

Catalog Number 8419600

Device Problems Material Erosion (1214); Gas Output Problem (1266); Failure to Deliver (2338); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation was started but is not yet concluded; results will be provided in a follow-up report.

Event Description

It was reported that the device turned off during ventilation.No patient consequences reported.

Manufacturer Narrative

In the course of investigation the device was checked on site and reported error codes were analyzed by the manufacturer.The described behavior could be confirmed, the evita xl carried out several warm starts between 10:16 and 10:17 on (b)(6) 2020.The error codes displayed at this time were associated with a faulty mixer cartridge o2.The resulting change in power consumption was detected by the internal monitoring and warm starts were performed in order to correct the issue.During a warm start (duration approx.8 seconds), the evita xl opens the airway system to allow spontaneous breathing.This process is accompanied by an alarm.If the boot sequence has been successfully completed, ventilation is continued with the previous parameters.Immediately after restart of the ventilation, a "mv low" alarm is generated, which continues until the applied volume is greater than the lower set limit value for the minute volume.The evita xl was manufactured in may 2010.It behaved according to its specification and generated alarms to inform the user about the deviation.The affected component was replaced on site by a service technician.A subsequent device test was passed without any deviations.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

Please refer to the initial report.

• Brand Name: EVITA XL
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10147476
• MDR Text Key: 194936249
• Report Number: 9611500-2020-00205
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K083050
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8419600
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1