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

Device Problem Failure to Deliver (2338)

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

Event Date 02/21/2020

Event Type  malfunction  

Event Description

Testing flow meter and oxygen was not flowing through flow meter.

• Brand Name: INTEGRATED FLOW METER
• Type of Device: FLOWMETER, NONBACK-PRESSURE COMPENSATED, BOURDON GAUGE
• Manufacturer (Section D): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031
• MDR Report Key: 9769270
• MDR Text Key: 181362675
• Report Number: 9769270
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• 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: 02/28/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1