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

Model Number 1020006

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burn(s) (1757); Complaint, Ill-Defined (2331)

Event Date 09/17/2014

Event Type  malfunction  

Event Description

The mfr received info alleging a pt lit a cigarette while using an everflo oxygen concentrator.The pt received burns and had respiratory complications and was admitted to the hospital.The device has yet to be returned to the mfr for valuation.A follow up report will be submitted when the mfr has completed the investigation.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS GEORGIA, INC.; kennesaw GA
• Manufacturer Contact: don mcandrews ; 1740 godlen mile hwy; monroeville, PA 15146 ; 7243873965
• MDR Report Key: 4168373
• MDR Text Key: 4871221
• Report Number: 1040777-2014-00027
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1020006
• Device Catalogue Number: 1020006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2014
• Initial Date FDA Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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