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

Model Number	1020007
Medical Device Problem Codes	Overheating of Device (1437); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging that the compressor was not working and there was housing damage with a burn mark on the front/top on an everflo device.The device was not in use on a patient at the time of the occurrence.The device has not been returned for evaluation at this time.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
The manufacturer previously reported receiving information alleging that the compressor was not working and there was housing damage with a burn mark on the front/top on an everflo device.The device was not in use on a patient at the time of the occurrence.The device was evaluated by third party service center and customer's complaint was reproduced.Due to the low oxygen of sieves, replacement is necessary.Additionally, the braided silicone tube is damaged, and the front cabinet is cracked.Inlet filter will be replaced due to preventive maintenance.
Additional Manufacturer Narrative
This report is being submitted to correct the description of event or problem previously reported as the complaint assessed as not reportable event.The device was evaluated by a third-party service center, and the customer's complaint regarding broken housing was reproduced.The device showed no signs of burning or burn marks, which had been previously reported on the housing.Additionally, the sieves needed to be replaced due to low oxygen levels, the braided silicone tube was found damaged, the front cabinet was cracked, and the inlet filter needed to be replaced as part of preventive maintenance.The device was returned unrepaired.Section, describe event or problem, problem code grid, evaluation method code grid, evaluation results code grid, conclusion code grid have been updated/corrected.

• Brand Name: EVERFLO
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 23065877
• Report Number: 2518422-2025-110247
• Device Sequence Number: 9850311
• 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
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 10/03/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 09/22/2025; 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2021
• 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