* FM-15UA-OH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-26 for * FM-15UA-OH manufactured by Ohio Medical Corporation.

Event Text Entries

[2695416] Patient nasal cannula was connected to wall-piped medical air via flow meter with yellow color coded christmas tree nipple adapter instead of connected to wall oxygen via flow meter oxygen with green color chrismas tree nipple adapter.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2568099
• MDR Report Key: 2568099
• Date Received: 2012-04-26
• Date of Report: 2012-04-26
• Date of Event: 2012-04-17
• Report Date: 2012-04-26
• Date Reported to FDA: 2012-04-26
• Date Added to Maude: 2012-05-10
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: *
• Generic Name: FLOWMETER, OXYGEN
• Product Code: CAX
• Date Received: 2012-04-26
• Model Number: *
• Catalog Number: FM-15UA-OH
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: OHIO MEDICAL CORPORATION
• Manufacturer Address: 1111 LAKESIDE DRIVE GURNEE IL 60031 US 60031

Device Sequence Number: 2

• Brand Name: *
• Generic Name: NIPPLE
• Product Code: CAX
• Date Received: 2012-04-26
• Model Number: *
• Catalog Number: 539-0120
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: PRECISION MEDICAL, INC.
• Manufacturer Address: 300 HELD DR. NORTHAMPTON PA 18067 US 18067

Device Sequence Number: 3

• Brand Name: AIRLIFE
• Generic Name: NIPPLE ADAPTERS
• Product Code: CAX
• Date Received: 2012-04-26
• Model Number: *
• Catalog Number: 001840
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: 7000 CARDINAL PLACE DUBLIN OH 43017 US 43017

Device Sequence Number: 4

• Brand Name: *
• Generic Name: NASAL CANNULA
• Product Code: CAT
• Date Received: 2012-04-26
• Model Number: *
• Catalog Number: 001325
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 US 60085

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-04-26