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

Model Number	1020002
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an everflo oxygen concentrator caught on fire.There was no report of patient harm or injury.The investigation is still ongoing.A follow up report will be filed when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported an everflo oxygen concentrator allegedly caught on fire.There was no report of patient harm or injury.Despite the three attempts to have the device returned for evaluation and investigation were unsuccessful.The reporter of the event stated there is no evidence or presumption that the incident occurred at the patient's home was a malfunction of the device.The device has not yet been returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12546540
• Report Number: 2518422-2021-04592
• Device Sequence Number: 1113307
• Product Code: CAW
• UDI-Device Identifier: 00606959032514
• UDI-Public: 00606959032514
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1020002
• Device Catalogue Number: 1020002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown