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

Model Number	1020008
Health Effect - Clinical Code	Death (1802)
Date of Event	10/16/2016
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging an everflo oxygen concentrator was involved in a house fire.The patient expired.The device is currently in police custody and is not returning to the manufacturer for evaluation at this time.A follow up report will be submitted when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported an everflo oxygen concentrator was allegedly involved in a house fire.The patient expired.Repeated attempts to have the device and components 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.The manufacturer received information from the reporter of the event that the device is not being returned to the manufacturer for evaluation.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS INC; 175 chastain meadows court; kennesaw GA 30144
• MDR Report Key: 6224756
• Report Number: 1040777-2017-00003
• Device Sequence Number: 19096050
• Product Code: CAW
• UDI-Device Identifier: 00606959032576
• UDI-Public: 00606959032576
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2016

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1020008
• Device Catalogue Number: 1020008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 04/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIPAP A40 SERIAL NUMBER (B)(4)
• Outcome Attributed to Adverse Event: Death