MAUDE Adverse Event Report: Respironics, Inc. EverFlo; Generator, Oxygen, Portable

Model Number	1020001
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information from a work order on an everflo 120v opi domestic device.Per work order received, the device was alarming, no loss of power alarm, noisy compressor, low purity of 20.9%, cases "melted", and cracked flow control.The problem was able to be duplicated due to faulty board causing audible loss of power alarm, faulty sieve assembly causing low purity and alarming, faulty compressor specs of 12lpm causing low purity and alarming, and foam blocked exhaust port causing overheating and melted cases.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow up report will be filed.

• 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 ; +1(724)733-0200
• MDR Report Key: 50398546
• Report Number: 2518422-2026-043728
• Device Sequence Number: 9173258
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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: 1020001
• Device Catalogue Number: 1020001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2021
• 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