MAUDE Adverse Event Report: ACCUTRON, INC. DIGITAL ULTRA FLUSHMOUNT PACKAGE H CHAIR; FLOWMETER

Model Number	56800-CHAIR
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient subject of the event sought medical evaluation following the reported event.The unit was removed from service.Accutron has requested that the unit subject of the reported event to be returned for evaluation.Our investigation into the reported event is in process.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure involving the digital ultra flushmount flowmeter, the patients o2 saturation began to drop.The procedure was stopped and medical intervention was administered.
Additional Manufacturer Narrative
The digital ultra flushmount flowmeter subject of reported event was returned for evaluation.No issues with the function or operation of the flowmeter were identified.The unit was confirmed to be operating according to specification; the reported event was unable to be duplicated.User facility personnel were counseled on the proper use and operation for the digital ultra flushmount flowmeter.The 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.The o2 flush button can be used to rapidly purge the lines of n2o.If patient does not show signs of quick recovery, remove nasal hood and treat with pure oxygen from either the o2 resuscitator fitting or an auxiliary oxygen tank using a demand valve, oxygen assisted manual resuscitator, or equivalent.Call for emergency assistance if rapid response is not achieved." no additional issues have been reported.

• Brand Name: DIGITAL ULTRA FLUSHMOUNT PACKAGE H CHAIR
• Common Device Name: FLOWMETER
• 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 ; 1733 west parkside ln.; phoenix, AZ 85027 ; 4403927453
• MDR Report Key: 18290959
• Report Number: 2020813-2023-00006
• Device Sequence Number: 6762191
• Product Code: BSZ
• UDI-Device Identifier: 00813830024258
• UDI-Public: (01)00813830024258
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K052335
• 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,Followup
• Report Date (Section B): 12/08/2023

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: 56800-CHAIR
• Device Catalogue Number: 56800-CHAIR
• Device Lot Number: (10)2787222
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 11/08/2023; Not provided
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 03/19/2024; 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown