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

Catalog Number 8419601

Device Problems Material Erosion (1214); Gas Output Problem (1266); Failure to Deliver (2338)

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

Event Date 03/19/2021

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 the display of the device went dark and air was released from the inspiratory nozzle.This was repeated several times.There were no patient consequences reported.

Event Description

It was reported that the display of the device went dark and air was released from the inspiratory nozzle.This was repeated several times.There were no patient consequences reported.

Manufacturer Narrative

The affected device was examined on site by the dräger service technician and the log file was made available for further investigation at the manufacturer¿s site.Based on the log file analysis, it could be confirmed, that the device performed several warm starts at the reported time on the 19th of march 2021 until it was switched off by the user at 12.55 p.M.A faulty o2 mixer cartridge was identified to be the root cause of the warm starts.During a warm start, the emergency breathing valve opens, allowing the patient to breathe spontaneously.A warm start is accompanied by an audible alarm and the display is turned dark.If the boot sequence of the warm start is successfully completed (duration approx.8 seconds), ventilation is continued with the previous parameters.In case of an unsuccessful warm start, the warm starts are repeated until the device is switched off.The device reacted as specified and attempted to remedy an internal deviation by warm starts until the device was switched off.The warm starts were alarmed accordingly.Replacing the o2 mixer cartridge remedied the issue; the device was finally tested according to the manufacturer¿s specification and made available for further use at the customer¿s site.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 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: 11663239
• MDR Text Key: 247492373
• Report Number: 9611500-2021-00156
• 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: 05/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8419601
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1