MAUDE Adverse Event Report: ACCUTRON, INC. CLEARVIEW NASAL MASK

Model Number	33037-10
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Accutron has requested additional information regarding the reported event and the current patient status.To date, we have not received a response with additional information.The user facility was provided with a copy of the instructions for use for the clearview nasal mask and clearview scavenging circuit as requested.The clearview nasal mask instructions for use states, "warnings: to be used only by a professional trained in the use of nitrous oxide, using titration method.Patient should always be closely monitored during nitrous oxide use.If patient has an adverse reaction, reduce or stop the flow of nitrous oxide as needed." a follow-up mdr will be submitted should additional information become available.
Event or Problem Description
The user facility reported that a patient experienced adverse effects after using a clearview nasal mask during a dental procedure.
Additional Manufacturer Narrative
Through follow-up with the user facility, accutron learned that more than one patient had adverse events from the clearview nasal mask.The user facility declined to provide the number of patients or dates of the events.It was reported that each patient recovered on their own with no medical treatment being sought or administered.No additional issues have been reported.

• Brand Name: CLEARVIEW NASAL MASK
• Common Device Name: MASK
• Manufacturer (Section D): ACCUTRON, INC.; 1733 west parkside ln.; phoenix AZ 85027
• Manufacturer (Section G): ACCUTRON, INC.; 1733 west parkside ln.; phoenix AZ 85027
• Manufacturer Contact: daniel davy ; 5960 heisley rd.; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15819741
• Report Number: 2020813-2022-00007
• Device Sequence Number: 14231479
• Product Code: KHA
• UDI-Device Identifier: 00813830025965
• UDI-Public: 00813830025965
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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: 33037-10
• Device Catalogue Number: 33037-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown