OHMEDA QUICK CONNECT * 539-2105

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-21 for OHMEDA QUICK CONNECT * 539-2105 manufactured by Cardinal Health.

Event Text Entries

[2998143] Patient was connected to medical air and not oxygen. We use piss (pin index safety system) flowmeters in the newer areas of the hospital and diss(diameter index safety system) flowmeters in the older wings. Either way you may not plug an oxygen flowmeter into an air outlet or vice versa. The nipple adapter that is used to attach a delivery device (e. G. Mask, nasal cannula) is the same size. We have green/yellow color coded nipples which are interchangeable. The problem arises when staff places the incorrect nipple onto the flowmeter and assumes that the nipple color denotes the delivered gas.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2843524
• MDR Report Key: 2843524
• Date Received: 2012-09-21
• Date of Report: 2012-09-21
• Date of Event: 2012-07-19
• Report Date: 2012-09-21
• Date Reported to FDA: 2012-09-21
• Date Added to Maude: 2012-11-23
• 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
• 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: OHMEDA QUICK CONNECT
• Generic Name: FLOWMETER, CALIBRATION, GAS, ADAPTER
• Product Code: BXY
• Date Received: 2012-09-21
• Model Number: *
• Catalog Number: 539-2105
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: 1430 WAUKEGAN ROAD WAUKEGAN IL 60085 US 60085

Device Sequence Number: 2

• Brand Name: OHMEDA QUICK CONNECT AIR
• Generic Name: FLOWMETER, CALIBRATION, GAS, CONNECTOR
• Product Code: BXY
• Date Received: 2012-09-21
• Model Number: *
• Catalog Number: 539-2205
• Lot Number: *
• ID Number: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: 1430 WAUKEGAN ROAD WAUKEGAN IL 60085 US 60085

Device Sequence Number: 3

• Brand Name: PRECISION MEDICAL 02 FLOW METER
• Generic Name: FLOWMETER, CALIBRATION, GAS, ADAPTER
• Product Code: BXY
• Date Received: 2012-09-21
• Model Number: *
• Catalog Number: IMFA1003, IMFA3003L
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: 1430 WAUKEGAN ROAD WAUKEGAN PA 60085 US 60085

Device Sequence Number: 4

• Brand Name: *
• Generic Name: FLOWMETER, CALIBRATION, GAS, ADAPTER
• Product Code: BXY
• Date Received: 2012-09-21
• Model Number: *
• Catalog Number: FM15OOHPT
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: CAREFUSION
• Manufacturer Address: 10020 PACIFIC MESA ROAD SAN DIEGO CA 92121 US 92121

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-09-21