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

Model Number	1020001
Medical Device Problem Codes	Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation of everflo device that the patient alleges that the device is alarming, and overheating.A device was returned to a third-party service center.During the evaluation of the device, they found out that the complaint was confirmed, the flow control was cracked, faulty fan causing overheating and alarming.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
Corrected information: device problem code: temperature problem - overheating of device.Evaluation results code: thermal problem - overheating problem identified.Component code grid: no information.

• Brand Name: EVERFLO
• 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: 19923830
• Report Number: 2518422-2024-49402
• Device Sequence Number: 8113380
• Product Code: CAW
• UDI-Device Identifier: 00606959022041
• UDI-Public: (01)00606959022041
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2022
• 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