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	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation from an end user, while using the everflo the board found burnt at fan to board connector.There is no allegation of patient harm, serious injury, or 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 board burnt at fan to board input connector and confirmed customer's complaint.Power cord was replaced due to damaged connectors, sieve beds were replaced due to low o2 level, main board was replaced due to burn/ damage and not working, fan was replaced due to burn damaged on fan unit, compressor was replaced due to damaged connectors, inlet filter was replaced due to preventive maintenance and whisper cap was replaced.In addition, o2 level was 94.5% and device testing was completed and 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: 21539641
• Report Number: 2518422-2025-028525
• Device Sequence Number: 7857682
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• 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