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

Model Number	1020009
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2003
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to an everflo oxygen concentrator.The complaint references a red alarm, defective pca, and a power cord.There is no allegation of patient harm or serious injury.No clinical or medical information was provided.The device was inspected and evaluated, and the power cord and main pca were replaced by a third-party service center.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
H3 other text : the device was evaluated by a third-party service center.

• Brand Name: EVERLFLO
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18529433
• Report Number: 2518422-2024-03061
• Device Sequence Number: 17738207
• Product Code: CAW
• UDI-Device Identifier: 00606959032583
• UDI-Public: 00606959032583
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: 1020009
• Device Catalogue Number: 1020009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2021
• 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