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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA D-VAPOR; ANESTHESIA UNIT VAPORIZERS
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DRÄGERWERK AG & CO. KGAA D-VAPOR; ANESTHESIA UNIT VAPORIZERS Back to Search Results
Catalog Number M35500
Device Problem Device Handling Problem (3265)
Patient Problems Pain (1994); Shock, Traumatic (2268)
Event Date 11/12/2020
Event Type  Injury  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that the sevoflurane vapor at the device was replaced with a d-vapor, when anesthesia was started.It was confirmed that the monitor did not recognize the anesthesia gas.The monitors were swapped, but this reportedly did not improve the situation.However, the surgery was continued.At the end of the surgery, it was confirmed that the patient was conscious (unanesthetized).As further reported by the biomed, it was an eye surgery, the patient remembers the awareness and suffered from pain due to ineffective anesthesia and mental sequel due to the fear experience.Based on preliminary analysis, it was found that the d-vapor was not properly connected to the anesthesia machine which explains that the monitor did not recognize anesthesia gas.
 
Manufacturer Narrative
The local service organization has visually inspected and tested the device whereby it was confirmed that it does not exhibit any malfunctions.It was admitted by the user that the recommended pre-use check was omitted whereby the improper mounting would have been detected.The ifu explains in detail how to perform the adaptation to the anesthesia workstation and how to provide the test; training materials are offered by dräger as well.Occupational societies for anesthetists require to perform pre-use checks and emphasize the importance of adequate patient monitoring.Patient specific settings for the alarm thresholds should ensure adequate warning in case of dosage deviations.Dräger finally concludes that a chain of use errors has contributed to the event: improper mounting and omission of the recommended test has led to a dosage deviation which was reportedly obvious from the readings of the patient gas monitor.The user however developed the perception that the issue is a monitoring problem and continued the surgery.This is a situation beyond the control mechanisms a manufacturer can establish.
 
Event Description
It was reported that the sevoflurane vapor at the device was replaced with a d-vapor, when anesthesia was started.It was confirmed that the monitor did not recognize the anesthesia gas.The monitors were swapped, but this reportedly did not improve the situation.However, the surgery was continued.At the end of the surgery, it was confirmed that the patient was conscious (unanesthetized).As further reported by the biomed, it was an eye surgery, the patient remembers the awareness and suffered from pain due to ineffective anesthesia and mental sequel due to the fear experience.Based on preliminary analysis, it was found that the d-vapor was not properly connected to the anesthesia machine which explains that the monitor did not recognize anesthesia gas.
 
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Brand Name
D-VAPOR
Type of Device
ANESTHESIA UNIT VAPORIZERS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM  23542
MDR Report Key10910492
MDR Text Key218493293
Report Number9611500-2020-00436
Device Sequence Number1
Product Code CAD
Combination Product (y/n)N
PMA/PMN Number
K042276
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 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberM35500
Was Device Available for Evaluation? No
Date Manufacturer Received01/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NA.; NA.
Patient Outcome(s) Required Intervention;
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