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	Insufficient Information (4580)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that patients felt temporarily disoriented during procedures involving the accutron digital ultra flowmeter.The reported event was confirmed to occur on four separate dates.
Additional Manufacturer Narrative
Accutron has contacted the user facility requesting the device subject of the reported event to be returned for evaluation.The investigation in the reported event is in process; a follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The accutron digital ultra flowmeter was returned for evaluation.During evaluation the unit was fully tested and no issues were noted with the function or operation of the device.The reported event could not be duplicated.The customer received a replacement digital ultra flowmeter; 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: 18159218
• Report Number: 2020813-2023-00005
• Device Sequence Number: 6588589
• Product Code: BSZ
• UDI-Device Identifier: 00813830024258
• UDI-Public: (01)00813830024258
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/17/2023

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)2888127
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 05/04/2024; 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• 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