Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V800; VENTILATORS, INTENSIVE CARE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DRÄGERWERK AG & CO. KGAA EVITA V800; VENTILATORS, INTENSIVE CARE Back to Search Results
Catalog Number 8422500
Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); No Flow (2991); Reset Problem (3019)
Patient Problem Insufficient Information (4580)
Event Date 12/21/2021
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 device rebooted during o2 therapy.No patient health consequences were reported.In case the breathing pressure (incl.Peep) drops to ambient, a deterioration in state of health cannot be excluded for patients with difficult lung/ventilation conditions.
 
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that the device rebooted during o2 therapy.No patient health consequences were reported.In case the breathing pressure (incl.Peep) drops to ambient, a deterioration in state of health cannot be excluded for patients with difficult lung/ventilation conditions.
 
Manufacturer Narrative
The log file of the affected evita v800 was made available and analyzed for the investigation.Based on the log file analysis, it was possible to understand that an unexpected failure of the screen display occurred on 21.12.2021, at 07:58 system time.Contrary to what was reported, this failure did not occur during ventilation.The unit had been switched to standby mode shortly before and settings for o2 therapy were being made.Further, log entries indicated that an internal software process could not be completed by the device in the expected time, whereupon the security software performed a restart of the entire device as a specified response, resolving the problem.In an automated continuous run under ventilation with customer settings, no failure of the software process for the screen display could be traced with an identical ventilator.As a safety feature of the system, the safety software analyzes and verifies the proper functioning of the device.In the event of a detected deviation of an internal software process for the screen display, the device initiates a restart of this software process.Ventilation is not affected and continues with unchanged settings.Meanwhile, the user can follow the continuous ventilation via the oled display of the ventilation unit and read safety-relevant parameters such as fio2 concentration, minute volume and airway pressure.If the restart of the internal software process cannot be successfully completed in the expected time, the safety software initiates a synchronous restart of the ventilation unit and the control unit.During the restart sequence, the safety valve is opened to the environment to allow the patient to breathe spontaneously.The deviation is indicated by an activated auxiliary acoustic alarm (piezo loudspeaker of the ventilator).The ventilator restart sequence lasts approximately 8 seconds until ventilation is automatically resumed with the last settings.Finally, the alarm message "ventilator restarted" with accompanying acoustic alarm is displayed on the screen and the additional acoustic alarm goes off automatically.The device reacted to a detected timeout in the software as prescribed and triggered synchronized restarts of the ventilator and the control unit.The user was alerted to the situation by an audible and visual alarm.There was no patient injury reported.
 
Event Description
It was reported that the device rebooted during o2 therapy.No patient health consequences were reported.In case the breathing pressure (incl.Peep) drops to ambient, a deterioration in state of health cannot be excluded for patients with difficult lung/ventilation conditions.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EVITA V800
Type of Device
VENTILATORS, INTENSIVE CARE
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM 
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM   23542
MDR Report Key13176053
MDR Text Key285610304
Report Number9611500-2022-00006
Device Sequence Number1
Product Code QOV
Combination Product (y/n)N
PMA/PMN Number
EUA200143
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8422500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-