MAUDE Adverse Event Report: OHIO MEDICAL LLC INTEGRATED FLOWMETER; FLOWMETER, NONBACK-PRESSURE COMPENSATED, BOURDON GAUGE

Device Problem No Flow (2991)

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

Event Date 10/22/2019

Event Type  malfunction  

Event Description

Noticed that oxygen was not flowing through flow meter when being set up for use on a patient.Manufacturer response for oxygen flow meter, integrated flowmeter (per site reporter).There is an issue with the o-ring on devices manufactured in 2016.

• Brand Name: INTEGRATED FLOWMETER
• Type of Device: FLOWMETER, NONBACK-PRESSURE COMPENSATED, BOURDON GAUGE
• Manufacturer (Section D): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031
• MDR Report Key: 9888222
• MDR Text Key: 185223691
• Report Number: 9888222
• Device Sequence Number: 1
• Product Code: CCN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/24/2020,02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2020
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1