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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
Device Problems Gas Output Problem (1266); Mechanical Problem (1384); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 Name
VITAERIS 320 PACKAGE
Type of Device
HYPERBARIC CHAMBER
Manufacturer (Section D)
OXYHEALTH, LLC
MDR Report Key7689303
MDR Text Key114197852
Report NumberMW5078391
Device Sequence Number1
Product Code CBF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
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
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/13/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age66 YR
Patient Weight56
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