MAUDE Adverse Event Report: HYPERBARIC TECHNOLOGIES VITAERES 320; 73 CBF

Model Number 15C37179

Device Problems Disconnection (1171); Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); Suffocation (2088)

Event Date 06/09/2011

Event Type  Injury  

Event Description

Occupant was placed in a portable soft-sided hyperbaric chamber and left unattended for several hours.Parents of deceased allege the aire hose leading from the oil-less air compressor to the chamber became detached during treatment and occupant suffocated from lack of air.One of the first responders indicated that the hose was attached.Ref mfr # 2438426-2014-0001.

• Brand Name: VITAERES 320
• Type of Device: 73 CBF
• Manufacturer (Section D): HYPERBARIC TECHNOLOGIES; 1 sam straton rd; amsterdam NY 12010
• Manufacturer (Section G): OXYHEALTH LLC; 10719 norwalk blvd; santa fe spgs CA 90670 000
• Manufacturer Contact: 10719 norwalk blvd; santa fe spgs, CA 90670-0000
• MDR Report Key: 3838661
• MDR Text Key: 4450983
• Report Number: 3006777109-2014-00001
• Device Sequence Number: 1
• Product Code: CBF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 15C37179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR