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

Model Number	1020014
Medical Device Problem Codes	Device Alarm System (1012); Crack (1135); Failure to Deliver (2338); Gas/Air Leak (2946); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device was evaluated by a fasc.
Event or Problem Description
The manufacturer was contacted about an everflo oxygen concentrator.Per the work order received by the fasc the sieves beds were blown, solenoid intermittent, the regulator was leaking, the compressor rattling, the pca board had lights, and the power cord was cut off.There was no allegation of patient harm or serious injury.No clinical information or medical information was specified.The fasc performed a comprehensive inspection and replaced the necessary parts.At this time, no further investigation can be performed.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 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: 18546156
• Report Number: 2518422-2024-03568
• Device Sequence Number: 9080565
• Product Code: CAW
• UDI-Device Identifier: 00606959032620
• UDI-Public: 00606959032620
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• 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: Other
• Device Model Number: 1020014
• Device Catalogue Number: 1020014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2020
• 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