EPOD CONSERVING DEVICE 1018000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2012-09-05 for EPOD CONSERVING DEVICE 1018000 manufactured by Respironics Inc..

Event Text Entries

[22192015] The manufacturer received info alleging an epod oxygen conserving device sparked and caught on fire while the oxygen cylinder was being emptied. There was no report of pt harm or injury. The device has yet to be returned to the manufacturer for investigation. A follow up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1040777-2012-00020
• MDR Report Key: 2742047
• Report Source: 06,08
• Date Received: 2012-09-05
• Date of Report: 2012-08-10
• Date of Event: 2012-08-10
• Date Mfgr Received: 2012-08-10
• Date Added to Maude: 2012-09-17
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: DON MCANDREWS
• Manufacturer Street: 1740 GOLDEN MILE HWY
• Manufacturer City: MONROEVILLE PA 15146
• Manufacturer Country: US
• Manufacturer Postal: 15146
• Manufacturer Phone: 7243873965
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EPOD CONSERVING DEVICE
• Generic Name: CONSERVER, OXYGEN
• Product Code: NFB
• Date Received: 2012-09-05
• Model Number: 1018000
• Catalog Number: 1018000
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RESPIRONICS INC.
• Manufacturer Address: KENNESAW GA US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-09-05