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

Catalog Number 8419600

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

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 device screen blacked out twice during patient use.The device was replaced.No patient injury reported.

Manufacturer Narrative

The affected device was analyzed by the hospitals biomed in communication with the dräger technical support.The log file confirms that the device initiated multiple restarts on (b)(6) 2020 at 10:01 pm due to an internal deviation.The device was immediately switched to standby by the user at 10:02 pm.The analysis concluded that a faulty pcb pneumatic controller was the root cause for the issue.The device was repaired by replacing the affected pcb.The device reacted as specified for this malfunction by initiating a warmstart in an attempt to solve the issue.During a warmstart the screen is switched to dark and an emergency-breathing valve opens to allow for spontaneous breathing.This is accompanied by an audible alarm.After successfully performing the reboot (duration approx.8 seconds) the ventilation is continued with the latest parameters.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

It was reported that the device screen blacked out twice during patient use.The device was replaced.No patient injury reported.

• 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: 10762736
• MDR Text Key: 213878406
• Report Number: 9611500-2020-00387
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• PMA/PMN Number: K083050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1