MAUDE Adverse Event Report: OHIO MEDICAL LLC OHIO MEDICAL; FLOWMETER

Model Number 6700-1260-907

Device Problem Gas Output Problem (1266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the instructions for use and service manual confirmed trouble shooting steps are identified for this possible malfunction.Device was returned on may 3, 2021 and evaluated by engineering.Flow accuracy was confirmed to be within specification, and there were no anomalies noted.This device was originally shipped in march of 2008.Original device history record was reviewed and there were no discrepancies noted.

Event Description

Medwatch 3500a report (b)(4) was received via usps on april 27, 2021.This medwatch report stated that this device was discovered after a different failure (see user report (b)(4) and mfg response 1419185-2021-00004).The hospital stock was reviewed and it was stated that a second device had no flow despite flowmeter reading at 2.5 liters per minute (lpm).

• Brand Name: OHIO MEDICAL
• Type of Device: FLOWMETER
• Manufacturer (Section D): OHIO MEDICAL LLC; 1111 lakeside dr; gurnee IL 60031
• MDR Report Key: 11794459
• MDR Text Key: 250655395
• Report Number: 1419185-2021-00005
• Device Sequence Number: 1
• Product Code: CAX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6700-1260-907
• Device Catalogue Number: 6700-1260-907
• Device Lot Number: F05081041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Date Manufacturer Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR