MAUDE Adverse Event Report: OHIO MEDICAL LLC AMVEX MINI CLICK STYLE GAS REGULATOR; PORTABLE OXYGEN REGULATOR / REGULATOR VACUUM

Model Number EB-GPM2-870RM-T

Device Problems Loose or Intermittent Connection (1371); Increase in Pressure (1491); Improper Flow or Infusion (2954); Separation Problem (4043)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

During normal use, device suddenly started flowing high pressure oxygen out of the pressure relief hole.This is one of multiple reports you will receive for the same model (different serial numbers) device with exactly the same failure.Mfr was notified multiple times with acknowledgement that a problem exists.Replacement units also failed.Device click knob also was not secure.Routinely came off of device.Oxygen tubing nipple also not secure.We constantly experienced the nipple separating from the device.

• Brand Name: AMVEX MINI CLICK STYLE GAS REGULATOR
• Type of Device: PORTABLE OXYGEN REGULATOR / REGULATOR VACUUM
• Manufacturer (Section D): OHIO MEDICAL LLC; 1111 lake side dr.; gurnee IL 60031
• MDR Report Key: 8495914
• MDR Text Key: 141374941
• Report Number: MW5085650
• Device Sequence Number: 1
• Product Code: CAN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EB-GPM2-870RM-T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: 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