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

Model Number	1039363
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Codes	Dyspnea (1816); Increased Respiratory Rate (2486)
Date of Event	10/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an everflo oxygen concentrator emitted a white powder.The patient became short of breath and was hospitalized for one day and was released.The device has yet to be returned to the manufacturer's service center for evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.
Additional Manufacturer Narrative
The manufacturer previously reported an everflo oxygen concentrator emitted a white powder.The patient was admitted to the hospital for one day for shortness of breath.The manufacturer received information that the device has been scrapped by the durable medical equipment (dme) supplier and is no longer available for investigation.

• Brand Name: EVERFLO OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS INC; 175 chastain meadows court; kennesaw GA 30144
• MDR Report Key: 6109167
• Report Number: 1040777-2016-00034
• Device Sequence Number: 747383
• Product Code: CAW
• UDI-Device Identifier: 00606959032675
• UDI-Public: 00606959032675
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K061261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2016

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: Medical Equipment Company Technician/Representative
• Device Model Number: 1039363
• Device Catalogue Number: 1039363
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/26/2016
• Supplement Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 11/17/2016
• Supplement Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 80 YR