OXYGEN GAS LINE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-30 for OXYGEN GAS LINE manufactured by .

Event Text Entries

[1214489] This event occurred in the newly remodeled outpatient oncology infusion center. It was determined that the line designated for oxygen contained medical air. The line designated for medical air contained oxygen. Patient had come for infusion services and was removed from his own oxygen tank and was placed on wall oxygen for the infusion. His oxygen saturations dropped and he was placed on an oxygen tank in the unit. His infusion was continued without event. The biomedicine department was called and their staff could not determine any problem with the gauges. The next day, respiratory therapy was contacted and determined that oxygen was not coming out of the line for oxygen. Dates of use: 2009. Event abated after use stopped or dose reduced? : no. Event reappeared after reintroduction? : no.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5012147
• MDR Report Key: 1431451
• Date Received: 2009-07-30
• Date of Report: 2009-07-30
• Date of Event: 2009-06-22
• Date Added to Maude: 2009-08-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: OXYGEN GAS LINE
• Generic Name: NONE
• Product Code: ECX
• Date Received: 2009-07-30
• Lot Number: MEDIAL GAS CER
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0

Device Sequence Number: 2

• Brand Name: MEDICAL GAS LINE
• Generic Name: NONE
• Product Code: ECX
• Date Received: 2009-07-30
• Lot Number: MEDICAL GAS CE
• Device Sequence No: 2
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2009-07-30