MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO INTL OPI 230V ITALY/CHILE; GENERATOR, OXYGEN, PORTABLE

Model Number	1020011
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device has not been returned to the manufacturer for analysis.
Event or Problem Description
The manufacturer received an allegation that the body work of the everflo device is deformed due to overheating.No allegations of patient harm, serious injury, or medical intervention are specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer received an allegation that the body work of the everflo device is deformed due to overheating.No allegations of patient harm, serious injury, or medical intervention are specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.**udi related data quality updates only** the udi in section d4 was previously reported in the incorrect format.The udi information has been updated to the correct format.
Additional Manufacturer Narrative
The manufacturer previously reported receiving an allegation that the bodywork of the everflo device is deformed due to overheating.No allegations of patient harm, serious injury, or medical intervention are specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Udi related data quality update.The udi in section d4 was previously reported in the incorrect format.The udi information has been updated to the correct format.
Additional Manufacturer Narrative
Previously reported as 'the manufacturer received an allegation that the body work of the everflo device is deformed due to overheating.No allegations of patient harm, serious injury, or medical intervention are specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete'.In this report, box b: adverse event or product problem (describe event or problem) as the manufacturer received an allegation that the body work of the everflo device is deformed due to overheating.There was no report of patient harm or injury.No medical intervention was required by the patient.The device was returned to third party service center and evaluated.Evaluation result stated that rear and front cabinet is cracked, sieves are clogged, tubing is kinked, but all test results passed.The manufacturer is submitting a final report at this time.If any additional information becomes available to the manufacturer at a later date, an addendum to this final report will be filed, box d: suspect medical device (operator of device), box g: all manufacturers (report source), box h: device manufacturers (evaluation method code grid, evaluation results code grid, conclusion code grid) have been corrected/updated.

• Brand Name: EVERFLO INTL OPI 230V ITALY/CHILE
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• 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: 18145883
• Report Number: 2518422-2023-30421
• Device Sequence Number: 6884551
• Product Code: CAW
• UDI-Device Identifier: 00606959032590
• UDI-Public: (01)00606959032590
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: IT
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/29/2025

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: Other
• Device Model Number: 1020011
• Device Catalogue Number: 1020011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 10/31/2023; 09/30/2025
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 08/02/2024; 08/08/2024; 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2023
• 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