MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO INTL OPI 230V; OXYGEN CONCENTRATOR

Model Number	1020008
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that an everflo device has no power.There was no serious patient harm or injury.The patient required no medical intervention.The device was returned to the manufacturer for evaluation.During evaluation of the device, the manufacturer visually inspected the device and found the capacitor burning out.In addition, sieves, compressor, power cord, rear cabinet, front cabinet and capacitor were replaced due to affected by the capacitor.The main board is also replaced.Lastly, device was retested and all tests passed.

• Brand Name: EVERFLO INTL OPI 230V
• 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: 21535041
• Report Number: 2518422-2025-028225
• Device Sequence Number: 15237247
• Product Code: CAW
• UDI-Device Identifier: 00606959032576
• UDI-Public: (01)00606959032576
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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: 1020008
• Device Catalogue Number: 1020008
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2023
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2020
• 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