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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OXYHEALTH LLC VITAERIS 320; PORTABLE HYPERBARIC CHAMBER
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OXYHEALTH LLC VITAERIS 320; PORTABLE HYPERBARIC CHAMBER Back to Search Results
Model Number VITAERIS 320
Health Effect - Clinical Code No Information (3190)
Date of Event 03/28/2017
Type of Reportable Event Serious Injury
Event or Problem Description
Over the past month, the inside zipper of our oxyhealth vitaeris 320 (sn (b)(4)) has come apart under the normal operating pressure of 4lbs pressure.Both the top and inside (lower) zipper were entirely zipped to the end of the zippers.The chamber was inflated to 4lbs (1.3ata) pressure for about two minutes at full inflation before there was a loud noise and the inside zipper came apart, and all air suddenly exhausted from the chamber (rapid deflation).After exiting the chamber, i was able to slide the zipper to the other end of the track, and then it zipped up fine again to the head-top end of the chamber and the chamber seemed to work fine.The top zipper was still totally zipped and not undone after the inside zipper fell apart.It has done this three times in the last month.We have not used the chamber since the last incident for fear of injuring patients.Oxyhealth has sent a zipper repair kit as a solution to fix the issue on my own.
 
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Brand Name
VITAERIS 320
Common Device Name
PORTABLE HYPERBARIC CHAMBER
Manufacturer (Section D)
OXYHEALTH LLC
santa fe springs CA 90670
MDR Report Key6459804
Report NumberMW5068900
Device Sequence Number841914
Product Code CBF
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/03/2017
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 Health Professional
Device Model NumberVITAERIS 320
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/03/2017
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 Required Intervention;
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