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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V800; VENTILATORS, INTENSIVE CARE
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DRÄGERWERK AG & CO. KGAA EVITA V800; VENTILATORS, INTENSIVE CARE Back to Search Results
Catalog Number 8422500
Device Problems Decrease in Pressure (1490); Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2023
Event Type  malfunction  
Event Description
It was reported that the affected device went off and restarted during use on a patient.The device then continued to run in the ventilation mode in which it was previously set.No patient harm was reported.
 
Manufacturer Narrative
The investigation has just started.Results will be provided in a follow-up report.
 
Manufacturer Narrative
The log file was available for investigation.The log file analysis confirmed that the affected device performed two independent restarts during ventilation on (b)(6) 2023.The investigation revealed that both restarts occurred in response to a transmitted command from the co2-sensor.Communication between the co2-sensor and the ventilation units takes place via a serial data transmission protocol.The command transmitted by the co2-sensor in this case is not provided for and not implemented in the current firmware of the co2-sensor.According to specifications, the ventilator responds to unknown commands by performing a restart of the system.The co2-sensor used at the time of failure was made available for further investigation.The specific command that caused the reboot at the customer site could not be reproduced during these investigations.The investigation revealed that the co2-sensor's insulation was locally damaged.Neither mechanical stress on the sensor cable nor immersion in a water bath could reproduce a malfunction.Data transmission via the serial data transmission protocol is digital and check sum checked, so potential emc interference and potential involvement of the defective insulation in the restart events was judged unlikely.In addition, the coupling process between co2-sensor and the ventilator was investigated as a possible cause for the command leading to the restarts.1200 initialization cycles on an independent ventilator using a test script were performed without error.Also 100 manual coupling cycles on an independent ventilator did not reveal any deviations.The cause of the unknown command in the communication path between the co2-sensor and the ventilator could not be conclusively determined.During a restart, ventilation is temporarily interrupted, and the secondary audible alarm signal of the ventilator unit is posted.Meanwhile, the inspiration valve is open against the environment to allow the patient to breathe spontaneously.After 8 seconds at the latest, evita v800 automatically continues ventilation with the former settings.Restart of the control unit is completed after one minute at the latest.Meanwhile, the user can follow the resumed ventilation on the oled display of the ventilation unit and read safety-relevant parameters.The restart is finally indicated by the alarm message "ventilation unit restarted" on the control unit with acoustic alarm tone sequence and the secondary acoustic alarm signal of the ventilation unit is terminated.The ventilator alarmed the restarts as intended and resumed ventilation after the restarts with the former settings.No patient harm was reported in this case.To date, no other comparable restart events for the product family (consisting of evita v800, evita v600, baby log vn800, baby log vn600) have come to dräger's attention from the field.Based on current knowledge, the results of this complaint investigation have not identified any new or additional risks that have not yet been addressed in the ventilator's risk management file.
 
Event Description
It was reported that the affected device went off and restarted during use on a patient.The device then continued to run in the ventilation mode in which it was previously set.No patient harm was reported.
 
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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
Manufacturer Contact
moislinger allee 53-55
lübeck 23542
4518822868
MDR Report Key16521118
MDR Text Key311142896
Report Number9611500-2023-00094
Device Sequence Number1
Product Code QOV
UDI-Device Identifier04048675542148
UDI-Public(01)04048675542148(11)200323(93)8422500-03
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 07/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2023
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 Received07/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NA.; NA.
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