MAUDE Adverse Event Report: OHIO MEDICAL LLC AMVEX; FLOWMETER

Device Problems Improper or Incorrect Procedure or Method (2017); Free or Unrestricted Flow (2945); Misassembly by Users (3133)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  malfunction  

Event Description

On march 16, 2021, ohio medical received medwatch report mw5099385 via (b)(6).Internal complaint files were reviewed, and it was determined that the user facility did not report directly to ohio medical.The medwatch report indicated that a flowmeter burst under pressure due to incorrect setup.On march 18, 2021, ohio medical contacted the initial reporter, (b)(6), via telephone for further information.(b)(6) was not available, so the investigation team left a voicemail notifying the initial reporter of the reason for the call.On march 23, 2021, a second attempt was made to contact (b)(6) through email.The investigation team requested additional information related to the reported event.On march 24, 2021, a response was received.(b)(6) indicated the event was not due to a manufacturing defect.The initial reporter confirmed the event was attributable to an incorrect system setup.The staff connected the co2 tank to the flowmeter without a regulator.The excessive pressure caused the flowmeter to burst when the tank valve was opened.There were no associated injuries relating to this complaint.

Manufacturer Narrative

The serial number reported by the user facility on medwatch was not identified as an amvex or ohio medical manufactured serial number.Initial reporter (b)(6) could not provide the correct serial number due to device has been destroyed.Manufacturing records could not be reviewed due to the lack of a serial number.Device ifu (instructions for use) was reviewed.Page two (2) states the following: never attempt to attach a flowmeter directly to a cylinder.Historical complaint data was reviewed and no other failures of this nature were observed.Ohio medical determined that this incident is user related based on the information provided by the initial reporter, review of instructions provided in device ifu, review of complaint trending.No remedial action is required at this time.

• Brand Name: AMVEX
• Type of Device: FLOWMETER
• Manufacturer (Section D): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031
• MDR Report Key: 11668032
• MDR Text Key: 280538374
• Report Number: 1419185-2021-00003
• Device Sequence Number: 1
• Product Code: CAX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other