VARIOUS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-05-11 for VARIOUS manufactured by Chemtron.

Event Text Entries

[1500609] Flowmeter separated from wall plate (oxygen supply), propelled from wall, narrowly missing pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5015928
• MDR Report Key: 1691027
• Date Received: 2010-05-11
• Date of Report: 2010-05-11
• Date of Event: 2010-04-28
• Date Added to Maude: 2010-05-17
• 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

• Generic Name: OXYGEN FLOWMETER
• Product Code: CAX
• Date Received: 2010-05-11
• Model Number: VARIOUS
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CHEMTRON

Device Sequence Number: 2

• Brand Name: QUICK CONNECT ADAPTER
• Generic Name: NPT MALE-OXYGEN
• Product Code: BYX
• Date Received: 2010-05-11
• Catalog Number: 12-01-1000
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: CHEMTRON

Device Sequence Number: 3

• Brand Name: QUICK CONNECT ADAPTER
• Generic Name: DISS MALE-OXYGEN
• Product Code: BYX
• Date Received: 2010-05-11
• Catalog Number: 12-01-3000
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: CHEMTRON

Device Sequence Number: 4

• Brand Name: QUICK CONNECT ADAPTER
• Generic Name: AIR
• Product Code: BYX
• Date Received: 2010-05-11
• Catalog Number: 12-01-1100
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: CHEMTRON

Device Sequence Number: 5

• Brand Name: QUICK CONNECT ADAPTER
• Generic Name: AIR
• Product Code: BYX
• Date Received: 2010-05-11
• Catalog Number: 12-01-3100
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: CHEMTRON

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-05-11