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

Model Number	1020006
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that after six hours of operation, the "ventilation tube" of an everflo device caught fire due to a small explosion.While trying to put it out, the patient reported that they burned their hand, and the freshly renovated wooden floor caught fire from the melted burning tube, which damaged the floor and affected the freshly painted wall.The fire was extinguished using a bottle of still mineral water, no further damage occurred.No medical intervention/treatment or further clinical details were reported.It was reported that the date of incident was (b)(6) 2026.The device settings during the event were reported to be unknown.There was no allegation of serious or permanent harm or injury.The clinical assessment states that, based on information available at this time, the reported event of unspecified burn to the hand is assessed as a non-serious injury.There was no report of medical intervention required or received to preclude a life-threatening injury or permanent impairment.Therefore, the device did not cause or contribute to a serious injury or death.' 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 ; 7247330200
• MDR Report Key: 25626952
• Report Number: 2518422-2026-025576
• Device Sequence Number: 9011746
• Product Code: CAW
• UDI-Device Identifier: 00606959032552
• UDI-Public: 00606959032552
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: Lay User/Patient
• Device Model Number: 1020006
• Device Catalogue Number: 1020006
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown