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

Model Number	1020017
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging tubing from an everflo oxygen concentrator ignited after switching off the device.The tubing was installed with a cpap device.There was no report of patient harm or injury.The device has yet to be returned for evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported.Information alleging, tubing from an everflo oxygen concentrator ignited, after switching off the device.The tubing was installed with a cpap device.There was no report of patient harm or injury.The device has yet to be returned for evaluation.A follow up report will be submitted, when the manufacturer has completed the investigation.The gfe for reclaiming the device was sent to the philips customer service representative on site.And which, contacts the hospital directly.The complaint was received on february 28, 2023.And follow-up attempts to obtain the device were made on may 24, 2023 and may 26, 2023.During a gfe attempt to retrieve the device, the manufacturer received an email with the following information."the tube of the o2 concentrator ignited, after the device was switched off and the cpap device installed.While the caregiver was briefly absent.The patient was alone in the room at the time of the incident.Patient uninjured, according to staff, there were no ignition sources in the patient's environment.Patient would not have triggered the event according to his own statement".On june 5th, 2023, the manufacture learned, that the device was scrapped (discarded).By the hospital sometime at the end of april 2023, due to a misunderstanding answer from philips.The device is unusable and disposed of.Further testing is therefore, no longer possible.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16591670
• Report Number: 2518422-2023-07452
• Device Sequence Number: 12093831
• Product Code: CAW
• UDI-Device Identifier: 00606959032651
• UDI-Public: 00606959032651
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2024

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: 1020017
• Device Catalogue Number: 1020017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2012
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown