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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA XL; VENTILATORS, INTENSIVE CARE
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DRÄGERWERK AG & CO. KGAA EVITA XL; VENTILATORS, INTENSIVE CARE Back to Search Results
Catalog Number 8414900
Device Problems Use of Incorrect Control/Treatment Settings (1126); Gas Output Problem (1266); Increase in Pressure (1491); Unexpected Therapeutic Results (1631)
Patient Problem Pneumothorax (2012)
Event Date 10/12/2020
Event Type  Injury  
Manufacturer Narrative
The investigation was started; the results will be provided in a follow-up report.
 
Event Description
It was reported, that the "ventilator delivered excessive pressure causing barotrauma to the patient with pneumothorax plus concern that patient may have sustained a stroke as a consequence.Patient subsequently had a cardiac arrest from which they were resuscitated within 2 minutes of commencing cpr.The patient was disconnected from the ventilator and hand ventilated.A chest x-ray revealed a pneumothorax and an intercostal drain was inserted.When patient was noted not to be moving left hand side, he was transferred for a ct.Ct did not reveal a stroke but may have been performed too early.".
 
Manufacturer Narrative
The affected device was tested onsite by a 3rd party technician as well as a dräger service technician and the logfile was provided for further investigation at the manufacturer¿s site.Based on the logfile analysis the reported event could be verified, however, a device malfunction could not be confirmed.The logged entries indicate that there was a large leak which was alarmed by the device.Furthermore, the device reacted as specified in order to compensate this leak within the user¿s settings and generated corresponding alarms when set alarm limits regarding flow and pressure were met.The device-specific instructions for use contains a warning that alarm limits have to be set according to the current patient¿s therapy requirements.Otherwise, the patient may be at risk.The instructions for use also provide information regarding leakage compensation.The electrical emergency valve limited the maximum airway pressure to the set alarm limit.A positive expiratory airway pressure (including peep) was maintained all the time and the peep-level was not below 2.9 mbar during the relevant period of time.Based on the device tests according to the manufacturer¿s specification there was no technical failure found.The internal pressure measurement system was additionally subjected to a comparative measurement using an external pressure meter (fluke) under calibrated conditions.As result of this measurement it could be shown that the internal pressure measurement system was in compliance with the external pressure measurement system within a tolerance of less than 0.5 mbar.Based on the investigation it could be concluded that the device reacted as specified in order to compensate a leak in the airway system.Appropriate alarms were generated according to the user¿s settings in order to alert the user of the situation.There was no device failure found.The number of similar cases, related to the same issue, is within the expected range of the respective risk assessment and thus accepted.
 
Event Description
It was reported, that the "ventilator delivered excessive pressure causing barotrauma to the patient with pneumothorax plus concern that patient may have sustained a stroke as a consequence.Patient subsequently had a cardiac arrest from which they were resuscitated within 2 minutes of commencing cpr.The patient was disconnected from the ventilator and hand ventilated.A chest x-ray revealed a pneumothorax and an intercostal drain was inserted.When patient was noted not to be moving left hand side, he was transferred for a ct.Ct did not reveal a stroke but may have been performed too early.".
 
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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 Key10784742
MDR Text Key214539901
Report Number9611500-2020-00398
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K083050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8414900
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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