PULSE DOSE EX2005D-16 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-24 for PULSE DOSE EX2005D-16 * manufactured by Devilbiss/sunrise Medical.

Event Text Entries

[350321] Employee was in hallway of nursing home unit, outside of storeroom. The pt was sitting in wheelchair near employee. Pt oxygen cyliner was empty. The employee obtained a full/new canister. They removed the flowmeter from empty canister and placed it on to new canister. As they turned the valve to open oxygen flow, flames shot up. Employee placed canister and placed it on to new canister. As they turned the valve to open oxygen flow, flames shot up. Employee placed cylinder on floor. Flame lasted approximately four minutes. Employee sustained burns to hands, arm and face. Pt was not injured. No one was smoking in the area.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1030348
• MDR Report Key: 500902
• Date Received: 2003-11-24
• Date of Report: 2003-11-24
• Date of Event: 2003-11-20
• Date Added to Maude: 2003-12-16
• 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
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PULSE DOSE
• Generic Name: OXYGEN FLOW METER
• Product Code: CCN
• Date Received: 2003-11-24
• Model Number: EX2005D-16
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 489671
• Manufacturer: DEVILBISS/SUNRISE MEDICAL
• Manufacturer Address: 100 DEVILBISS DR SOMERSET PA 15501 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2003-11-24