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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OXYHEALTH, LLC VITAERIS 320 PACKAGE HYPERBARIC CHAMBER

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OXYHEALTH, LLC VITAERIS 320 PACKAGE HYPERBARIC CHAMBER Back to Search Results
Model Number V320
Event Date 07/09/2018
Event Type  Malfunction  
Event Description

Used an oxyhealth vitaeris 320. The oxygen concentrator package they sold directly to me stopped working and started rumbling loudly and couldn't breathe while in the unit, the mask was not supplying oxygen. I called them to complain and they claimed they don't sell it, but i have an invoice of the product and spent the money, oxyhealth said they would give me a deal and charge (b)(6). However, when i called they said they don't sell it and won't fix the concentrator.

 
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Brand NameVITAERIS 320 PACKAGE
Type of DeviceHYPERBARIC CHAMBER
Manufacturer (Section D)
OXYHEALTH, LLC
MDR Report Key7689303
Report NumberMW5078391
Device Sequence Number1
Product CodeCBF
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 07/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberV320
Device Catalogue NumberVITAERIS
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/13/2018 Patient Sequence Number: 1
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