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

Model Number 1020000

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 06/30/2018

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient lit a cigarette while using an everflo oxygen concentrator.The patient received burns to his face and sought medical treatment.The investigation is still ongoing.A follow up report will be filed when the manufacturer has completed the investigation.

Manufacturer Narrative

Repeated attempts to have the device returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• MDR Report Key: 7691203
• MDR Text Key: 114085547
• Report Number: 1040777-2018-00028
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959014954
• UDI-Public: 00606959014954
• Combination Product (y/n): N
• PMA/PMN Number: K061261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

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: 1020000
• Device Catalogue Number: 1020000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 12/18/2018
• Supplement Dates FDA Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MICRO ELITE NEBULIZER; MICRO ELITE NEBULIZER
• Patient Outcome(s): Hospitalization