MAUDE Adverse Event Report: AMVEX CORPORATION / OHIO MEDICAL LLC AMVEX (OHIO MEDICAL) FMA 4906 FLOWMETER; FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED

Model Number FMA 4906

Device Problems Burst Container or Vessel (1074); Misassembly by Users (3133)

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

Event Date 02/02/2021

Event Type  Injury  

Event Description

During an endoscopic procedure, the co2 flowmeter was connected directly to the gas cannister through a hose without a regulator inline between the cannister and the flowmeter.The flowmeter immediately burst under the pressure when the cannister flow was initiated.There was no injury to the patient.This was determined to be an error in component setup by staff.Imaging was performed to ensure that no shards of glass were on or in the patient, but the patient was covered at the time of the flowmeter bursting.Fda safety report id# (b)(4).

• Brand Name: AMVEX (OHIO MEDICAL) FMA 4906 FLOWMETER
• Type of Device: FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED
• Manufacturer (Section D): AMVEX CORPORATION / OHIO MEDICAL LLC; 1111 lakeside dr.; IL 60031
• MDR Report Key: 11332263
• MDR Text Key: 232219299
• Report Number: MW5099385
• Device Sequence Number: 1
• Product Code: CAX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FMA 4906
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Weight: 89