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

Model Number	1020008
Medical Device Problem Codes	Unexpected Shutdown (4019); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an everflo oxygen concentrator was not producing oxygen while in patient use.The patient reportedly became breathless and was hospitalized.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be filed when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported an everflo oxygen concentrator was allegedly not producing oxygen while in patient use.The manufacturer used the incorrect code for medical device problem code in section h6.The correct code is 4019, unexpected shut down, updated in section h6.
Additional Manufacturer Narrative
The manufacturer previously reported an everflo oxygen concentrator was allegedly not producing oxygen while in patient use.The patient reportedly became breathless and was hospitalized.The manufacturer received information that the patient was not hospitalized.
Additional Manufacturer Narrative
The manufacturer previously reported an everflo oxygen concentrator was allegedly not producing oxygen while in patient use.The patient reportedly became breathless.The device was returned to the manufacturer's quality product investigation laboratory for further investigation.The manufacturer visually inspected the device and found evidence of physical damage, rust/corrosion and contamination of dust and dirt.The manufacturer found the sieve canister regulatory to be removed or separated from the sieve top enclosure.The device was tested and the manufacturer confirmed the device does not provide flow/therapy due to the separation of the pressure/flow regulator from the sieve canister.The main pca was found to be producing a system fault alarm.The manufacturer concludes the customer's complaint was confirmed.The manufacturer found phsyical damage to the device, causing the failure.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 15009542
• Report Number: 2518422-2022-60196
• Device Sequence Number: 20547294
• Product Code: CAW
• UDI-Device Identifier: 00606959032576
• UDI-Public: 00606959032576
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1020008
• Device Catalogue Number: 1020008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 07/29/2022; 08/05/2022; 09/28/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 07/29/2022; 08/05/2022; 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2021
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown