MAUDE Adverse Event Report: WESTERN/SCOTT FETZER CO. MEDICAL GAS FLOWMETER REGULATOR

Model Number	M1-540-15FM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An adulterated medical gas flowmeter ruptured during a nonmedical application of the device used outside the specified temperature range.

• Brand Name: MEDICAL GAS FLOWMETER REGULATOR
• Common Device Name: FLOWMETER REGULATOR
• Manufacturer (Section D): WESTERN/SCOTT FETZER CO.; 875 bassett road; westlake OH 44145
• Manufacturer (Section G): WESTERN/SCOTT FETZER CO.; 875 bassett road; westlake OH 44145
• Manufacturer Contact: lindyn humenik ; 875 bassett road; westlake, OH 44145 ; 4408726471
• MDR Report Key: 16494986
• Report Number: 1526809-2023-00001
• Device Sequence Number: 17794933
• Product Code: CAX
• UDI-Device Identifier: B929M154015FM0
• UDI-Public: B929M154015FM0
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A#S-P#N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: M1-540-15FM
• Device Catalogue Number: M1-540-15FM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown