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

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.

• Brand Name: ANESTHESIA MACHINE
• Type of Device: GAS-MACHINE, ANESTHESIA
• MDR Report Key: 13153049
• MDR Text Key: 283268111
• Report Number: MW5106443
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 01/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: KEPPRA 250MG BID; LEVOTHYROIXINE 50MCG ; SEVOFLO; ZOETIS
• Patient Outcome(s): Disability; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White