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

Model Number	1020011
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Gas Output Problem (1266); Leak/Splash (1354); Pressure Problem (3012); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging not compliance pressure.During the evaluation of the device at the third-party service center, the device was visually inspected and found compressor burn.Additionally, flowmeter is crack, sieves is clogged, o2 body and valves is defective.The customer complaint was reproduced.There was no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.The device has not yet been returned to the manufacturer for evaluation.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
The manufacturer previously received information alleging not compliance pressure.During the evaluation of the device at the third-party service center, the device was visually inspected and found compressor burn.Additionally, flowmeter is crack, sieves is clogged, o2 body and valves is defective.The customer complaint was reproduced.There was no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.The device has not yet been returned to the manufacturer for evaluation.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Previously mentioned event description was incorrect.The correct/updated event description should be- the manufacturer received information alleging an issue with the pressure related to the device everflo intl opi.There was no report of patient harm or injury.The device was returned to the third-party service center for further evaluation.During the evaluation of the device at the third-party service center, the device was visually inspected and found thermal event as the compressor is burnt.Additionally, flowmeter was cracked, sieves are clogged, o2 body and valves is defective, inlet filters need to be changed due to preventive maintenance.Flowmeter, compressor, sieves, o2 body, inlet filter and valves were replaced.The customer complaint was reproduced.All test results passed.In this report, box d, g, h has been updated/ corrected.

• Brand Name: EVERFLO
• Common Device Name: OXYGEN CONCENTRATOR
• 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: 21201026
• Report Number: 2518422-2025-006068
• Device Sequence Number: 7544861
• Product Code: CAW
• UDI-Device Identifier: 00606959032590
• UDI-Public: (01)00606959032590
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: IT
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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: 1020011
• Device Catalogue Number: 1020011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown