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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VITAERIS / OXYHEALTH LLC HYPERBARIC CHAMBER CHAMBER, HYPERBARIC

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VITAERIS / OXYHEALTH LLC HYPERBARIC CHAMBER CHAMBER, HYPERBARIC Back to Search Results
Model Number 320
Event Date 10/01/2011
Event Type  Malfunction  
Event Description

Window seam broke.

 
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Brand NameHYPERBARIC CHAMBER
Type of DeviceCHAMBER, HYPERBARIC
Manufacturer (Section D)
VITAERIS / OXYHEALTH LLC
MDR Report Key6875912
Report NumberMW5072201
Device Sequence Number1
Product CodeCBF
Report Source Voluntary
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 09/17/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/18/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number320
Was Device Available For Evaluation? Yes
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

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