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

Model Number FMAO#####XX

Device Problems Crack (1135); Peeled/Delaminated (1454); Defective Component (2292)

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).

• 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: 9123088
• MDR Text Key: 160189384
• Report Number: 9123088
• 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: 08/23/2019,08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• 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: 08/23/2019
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1