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

Model Number M1-540-15FM

Device Problems Material Rupture (1546); Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2023

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 310808883
• Report Number: 1526809-2023-00001
• Device Sequence Number: 1
• Product Code: CAX
• UDI-Device Identifier: B929M154015FM0
• UDI-Public: B929M154015FM0
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A#S-P#N/A
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization