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

Model Number	1020007
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging fuse on the circuit board defective related to the device everflo intl oxygen concentrator.There was no report of patient harm or injury.No medical intervention was specified.The device was returned to the third-party service center for evaluation.During the evaluation of the device at the third-party service center, the device was visually inspected and clogged sieves, contaminated silicone braided tube, inlet filter that need to be changed due to preventive maintenance, contaminated manifold, defective pca (fuse broken), damaged overlay kit were found.The customer complaint was reproduced.Lastly the device passed all test results.The device pca was forwarded to the manufacturer's product investigation laboratory from third party service center to further investigate an allegation of "blowing fuses/thermal event".The investigation confirmed that the pca appeared to have received a mains vac voltage spike/eos/esd event or an incorrect mains voltage connection during servicing.The incoming mains mov conductors have experienced a physical departure and subsequent thermal creep event from an over voltage condition.Components vented as designed (metal oxide resistor and power inlet fuse.) the thermal creep was confirmed; however, it was isolated to the components/pca substrate trace.The pca with thermal damage originated external of the unit.The materials were scrapped/recycled as appropriate.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 INTL
• 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: 22149073
• Report Number: 2518422-2025-046589
• Device Sequence Number: 8308754
• Product Code: CAW
• UDI-Device Identifier: 00606959032569
• UDI-Public: (01)00606959032569
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2025

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: 1020007
• Device Catalogue Number: 1020007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2019
• 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