MAUDE Adverse Event Report: OHIO MEDICAL LLC OHIO MEDICAL INTEGRATED OXYGEN FLOWMETER; ANALYZER, GAS, OXYGEN, GASEOUS - PHASE

Model Number FI-T15UO-DN-E

Device Problems Inaccurate Flow Rate (1249); Improper Flow or Infusion (2954)

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

Event Date 11/06/2019

Event Type  malfunction  

Event Description

Ohio medical oxygen flowmeters did not function as required.The oxygen flow did not maintain a steady state leading to incorrect flow rate setting.Fda safety report id# (b)(4).

• Brand Name: OHIO MEDICAL INTEGRATED OXYGEN FLOWMETER
• Type of Device: ANALYZER, GAS, OXYGEN, GASEOUS - PHASE
• Manufacturer (Section D): OHIO MEDICAL LLC ; gurnee IL 60031
• MDR Report Key: 9511352
• MDR Text Key: 172617669
• Report Number: MW5091848
• Device Sequence Number: 4
• Product Code: CCL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/19/2019
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FI-T15UO-DN-E
• Device Catalogue Number: IFM0-15 LPM TUBE US OXY DISS
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1