MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO OXYGEN CONCENTRATOR; GENERTOR, OXYGEN, PORTABLE

Model Number 1020000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Date 06/17/2013

Event Type  Injury  

Event Description

The mfr received info alleging a pt was smoking a cigarette while using an everflo oxygen concentrator occurring approximately six to eight months ago.The cigarette ignited a fire and the pt received severe burns and was admitted to the hosp for treatment.

Manufacturer Narrative

The mfr received info from the durable medical equipment supplier (dme) that the reported event occurred over a year ago.The dme reported the fire marshal confirmed the fire was caused by someone smoking with oxygen present in the room.The mfr received info from the dme that the device was destroyed; therefore, the device is unavailable for eval.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: GENERTOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; kennesaw GA
• Manufacturer Contact: don mcandrews ; 1740 golden mile highway; monroeville, PA 15146 ; 7243873965
• MDR Report Key: 3934578
• MDR Text Key: 20699838
• Report Number: 1040777-2014-00015
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1020000
• Device Catalogue Number: 1020000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR