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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. VAPORIZER; VAPORIZER, ANESTHESIA, NON-HEATED
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DRAEGER MEDICAL SYSTEMS, INC. VAPORIZER; VAPORIZER, ANESTHESIA, NON-HEATED Back to Search Results
Model Number M35170
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2017
Event Type  malfunction  
Event Description
It was reported that after intravenous induction of general anesthesia for a patient undergoing biliary endoscopy, patient was reportedly placed on a ventilator and subsequently received sevoflurane.A sevoflurane expired level was reportedly not visible on the patient monitor.Attempts were then made to "trouble shoot" the monitor.Procedure was started after which fentanyl and propofol were administered.A portable gas analyzer reportedly confirmed no sevoflurane level.A new sevoflurane vaporizer was then placed on the anesthesia machine after which a sevoflurane level appeared on the monitor.Sevoflurane was then administered as the anesthetic.Procedure was completed without incident; however patient reported awareness under anesthesia after completion.Patient denied having any pain during the procedure.Continued follow up with the patient is planned.
 
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Brand Name
VAPORIZER
Type of Device
VAPORIZER, ANESTHESIA, NON-HEATED
Manufacturer (Section D)
DRAEGER MEDICAL SYSTEMS, INC.
6 tech dr.
andover MA 01810
MDR Report Key6618182
MDR Text Key76851737
Report Number6618182
Device Sequence Number1
Product Code CAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2017
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberM35170
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/19/2017
Event Location Hospital
Date Report to Manufacturer05/19/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NOT KNOWN.; UNKNOWN.
Patient Age68 YR
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