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

Model Number	1020001
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
The manufacturer received information on everflo device alleging smoke.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
• 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: 19374935
• Report Number: 2518422-2024-30178
• Device Sequence Number: 7619752
• Product Code: CAW
• UDI-Device Identifier: 00606959022041
• UDI-Public: 00606959022041
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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: 1020001
• Device Catalogue Number: 1020001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2020
• 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