MAUDE Adverse Event Report: OHIO MEDICAL AMVEX; FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED

Model Number FMAO#####XX

Device Problems Crack (1135); Peeled/Delaminated (1454)

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

Event Date 07/31/2019

Event Type  malfunction  

Event Description

The clear hood, part# 7700-0010-500, on amvex (ohio medical) oxygen flowmeters are showing signs of plastic delamination and cracks.These flowmeters are within 1 and 3 years old.This report only covers a partial list of defective flowmeters (qty 62) as we are continuing to replace this clear plastic hood across our facility.Here is the list of oxygen.Flowmeters (b)(4).Manufacturer response for oxygen flowmeter (qty 62), amvex (per site reporter).Ohio medical has been contacted.We are waiting for further corrective action from them.Email from manufacturer: i will start to set up a return for the hoods to be sent back.Do you happen to know what type of cleaner is being used on the flowmeters and regulators in between patients when they wipe them down? i know they will want to have that included in the report.

• Brand Name: AMVEX
• Type of Device: FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED
• Manufacturer (Section D): OHIO MEDICAL; 1111 lakeside drive; gurnee IL 60031
• MDR Report Key: 8990994
• MDR Text Key: 157416340
• Report Number: 8990994
• Device Sequence Number: 1
• Product Code: CAX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FMAO#####XX
• Device Catalogue Number: FMAO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2019
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1