MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO 120V OPI DOMESTIC; GENERATOR, OXYGEN, PORTABLE

Model Number	1020001
Medical Device Problem Codes	Contamination (1120); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information in relation to an everflo 120v opi.The user alleges the plastic parts was melting.The device has not yet been returned to the manufacturer for investigation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
The manufacturer received information in relation to an everflo 120v opi.The user alleges the plastic parts was melting.The device was returned to the third-party service centre for further evaluation.Visual inspection: external: appears to have several notable instances of neglect.Evidence of a dropped condition, liquid ingress, lack of preventative maintenance.Internal: old/used/worn/dirty, significant neglect.Furthermore, compressor manifold is damaged and compressor inlet not making good seal from manifold.Verification: enclosure plastics are warped but do not show any signs of thermal event.Unit producing therapy as designed.Visual inspection confirms physical damage and lack of preventative maintenance.Unit has 17603.0 hours use.While evidence of physical damage can be found throughout, unit functions as designed.Summary: confirmed allegation, uit neglected/physical damage/liquid ingress.Recommend unit processed through service department for pm/conformance check/revision and upgrades.

• Brand Name: EVERFLO 120V OPI DOMESTIC
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 20158766
• Report Number: 2518422-2024-56961
• Device Sequence Number: 8368624
• Product Code: CAW
• UDI-Device Identifier: 00606959022041
• UDI-Public: (01)00606959022041
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 1020001
• Device Catalogue Number: 1020001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2021
• 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