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

Model Number 1020000

Device Problems Fire (1245); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 06/28/2018

Event Type  Injury  

Event Description

The manufacturer received a voluntary medwatch, report number (b)(4), alleging a patient lit a cigarette while using an everflo oxygen concentrator.The patient received first degree burns to her chest and abdomen.The patient was admitted to the hospital for first degree burns and copd exacerbation related to smoke inhalation.The investigation is still ongoing.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a patient allegedly lit a cigarette while using an everflo oxygen concentrator.The patient received first degree burns to her chest and abdomen.The patient was admitted to the hospital for first degree burns and copd exacerbation related to smoke inhalation.The durable medical equipment (dme) confirmed that the device will not be returning for investigation.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• Manufacturer (Section G): RESPIRONICS, INC.; 175 chastian meadows court; kennesaw GA 30144 3724
• Manufacturer Contact: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 7703697
• MDR Text Key: 114479014
• Report Number: 1040777-2018-00029
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959014954
• UDI-Public: 00606959014954
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

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: 07/17/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 08/21/2018
• Supplement Dates FDA Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2017
• 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: 70 YR