MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA 4; VENTILATORS, INTENSIVE CARE

Catalog Number 8411740

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

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.Device evaluated by manufacturer? on-going.

Event Description

It was reported that in the early morning hours of the (b)(6) 2020 on the intensive care unit of the hospital the intensive care ventilator evita 4 generated an alarm.The device stopped ventilating during its use and tried to reboot several times without success.This reportedly caused a life-threatening situation for the patient.It was also reported that the patient was resuscitated.

Manufacturer Narrative

The affected device was examined on site by the dräger service technician and the logbook was made available to the manufacturer for further investigation of the event.The logbook analysis considered that the device was still set to summertime.Based on the on-site device test and the logbook analysis, the reported event could be confirmed.Due to a malfunction of the mixer cartridge air, the device repeatedly performed warm starts on (b)(6) 2020 starting at 05:11 a.M.As a safety feature of the ventilator, the device software analyzes and verifies proper software operation and hardware function.If this internal monitoring detects a deviation, the device generates a corresponding visual and acoustical alarm in order to alert the user of the deviation.As a remedy measure a warm start might be initiated.For a warm start, the device briefly switches off and then on again.During this time, an emergency breathing valve opens, allowing the patient to breathe spontaneously.If the boot sequence of the warm start is successfully completed (duration approx.8 seconds), ventilation is continued with the previous parameters.Directly with the start of ventilation an alarm "mv low" is triggered, which continues until the applied volume is greater than the lower set limit for the minute volume.In case of an unsuccessful warm start a continuous acoustic alarm would be activated, and the emergency breathing valve would remain open.The warm starts are repeated until the unit is switched off.The affected device reacted as specified and attempted to remedy an internal deviation by warm starts.The warm starts were alarmed accordingly.Replacing the faulty mixer cartridge air remedied the issue.The final device test according to the manufacturer's specification was carried out successfully.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 in the early morning hours of (b)(6) 2020 on the intensive care unit of the hospital the intensive care ventilator evita 4 generated an alarm.The device stopped ventilating during its use and tried to reboot several times without success.This reportedly caused a life-threatening situation for the patient.It was also reported that the patient was resuscitated.

• Brand Name: EVITA 4
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10913817
• MDR Text Key: 218511173
• Report Number: 9611500-2020-00439
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K980642
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8411740
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 11/27/2020
• Supplement Dates Manufacturer Received: 12/21/2020
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention