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

Model Number 1039363

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

Patient Problems Burn(s) (1757); Respiratory Distress (2045); Burn, Thermal (2530)

Event Date 02/06/2018

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient lit a cigarette while using an everflo oxygen concentrator.The patient was admitted to the hospital with facial burns and smoke inhalation.There was no allegation of device malfunction.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported an everflo oxygen concentrator that a patient allegedly lit a cigarette while using.The patient was admitted to the hospital with facial burns and smoke inhalation.There was no allegation of device malfunction.The device was returned to the manufacturer's service center for evaluation.The device was visually inspected and found no evidence of fire damage.The device was contaminated with cigarette odor.The device was tested and was found to have a low oxygen concentration.The device is not being repaired by the request of the durable medical equipment (dme) supplier.

• 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: 7270678
• MDR Text Key: 100072048
• Report Number: 1040777-2018-00007
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00606959032675
• UDI-Public: 00606959032675
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

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: 1039363
• Device Catalogue Number: 1039363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 02/14/2018
• Supplement Dates Manufacturer Received: 03/28/2018
• Supplement Dates FDA Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2011
• 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: 78 YR