MAUDE Adverse Event Report: ACCUTRON INC ULTRA DC FLOWMETER; ANESTHESIA GAS MACHINE

Model Number	31980
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Sleepiness/Drowsiness/Somnolence (4850)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has not been returned for investigation.
Event or Problem Description
Pediatric patient was unable to wake up after procedure.Emergency services were called but patient woke up before their arrival.Patient is fine now.

• Brand Name: ULTRA DC FLOWMETER
• Common Device Name: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): ACCUTRON INC; 1625 w pinnacle peak; phoenix AZ 85027
• Manufacturer (Section G): ACCUTRON INC; 1625 w pinnacle peak; phoenix AZ 85027
• Manufacturer Contact: stephanie wasielewski ; 1625 w. pinnacle peak; phoenix, AZ 85027
• MDR Report Key: 24781789
• Report Number: 2020813-2026-00002
• Device Sequence Number: 12295473
• Product Code: BSZ
• UDI-Device Identifier: 00813830021219
• UDI-Public: (01)00813830021219
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K970163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 31980
• Device Catalogue Number: 31980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown