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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. EVERFLO OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE
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RESPIRONICS, INC. EVERFLO OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number 1039364
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Death (1802)
Date of Event 02/16/2018
Type of Reportable Event Death
Event or Problem Description
The manufacturer received information alleging a patient became disconnected from the everflo oxygen concentrator and expired.The device is not returning to the manufacturer for evaluation.There was no allegation of device malfunction that caused or contributed to the patient's death.It was reported to the manufacturer that the device operated properly at the durable medical equipment (dme) supplier when tested.Product labeling states, "the device is not intended to be life supporting or life sustaining.".
 
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Brand Name
EVERFLO OXYGEN CONCENTRATOR
Common Device Name
GENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
RESPIRONICS, INC.
175 chastian meadows court
kennesaw GA 30144 3724
MDR Report Key7303972
Report Number1040777-2018-00010
Device Sequence Number13903577
Product Code CAW
UDI-Device Identifier00606959032682
UDI-Public00606959032682
Combination Product (Y/N)N
PMA/510(K) Number
K061261
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/21/2018
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? No
Operator of Device Lay User/Patient
Device Model Number1039364
Device Catalogue Number1039364
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/21/2018
Initial Report FDA Received Date02/28/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Death;
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