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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANESTHESIA MACHINE GAS-MACHINE, ANESTHESIA

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ANESTHESIA MACHINE GAS-MACHINE, ANESTHESIA Back to Search Results
Device Problem Connection Problem (2900)
Patient Problems Headache (1880); Nausea (1970); Lethargy (2560); Convulsion/Seizure (4406)
Event Date 11/18/2021
Event Type  Injury  
Event Description
I was feeling nauseous, intermittent migraine, and lethargy, multiple times in the work place. Our anesthesia machine was isoflurane and was switched to sevoflurane mid (b)(6) 2021 and intermittently was smelling sevoflurane gas during procedure and the staff started have intermittent head aches and feeling unwell. We found out 4 weeks later we found the anesthesia machine was originally hooked up incorrectly to the scavenging system. On the day of (b)(6) 2021 during work i had a migraine and was very lethargic that required me to have a nap after work, which was very unusual for me. After the 2 hours nap i didn't feel well, nauseous but forced myself to eat something for dinner (had an apple with peanut butter just so i had something to eat, then i put my kids to bed and i had a seizure that night. I was taken by ambulance and another seizure was noted on the eeg that was done at the hospital.
 
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Brand NameANESTHESIA MACHINE
Type of DeviceGAS-MACHINE, ANESTHESIA
MDR Report Key13153049
MDR Text Key283268111
Report NumberMW5106443
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 01/03/2022 Patient Sequence Number: 1
Treatment
KEPPRA 250MG BID; LEVOTHYROIXINE 50MCG ; SEVOFLO; ZOETIS
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