VITAERES 320 15C37179

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-21 for VITAERES 320 15C37179 manufactured by Hyperbaric Technologies.

Event Text Entries

[4450983] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3006777109-2014-00001
• MDR Report Key: 3838661
• Date Received: 2014-05-21
• Date of Report: 2014-04-22
• Date of Event: 2011-06-09
• Date Added to Maude: 2014-05-29
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: 10719 NORWALK BLVD
• Manufacturer City: SANTA FE SPGS CA 906700000
• Manufacturer Country: US
• Manufacturer Postal: 906700000
• Manufacturer G1: OXYHEALTH LLC
• Manufacturer Street: 10719 NORWALK BLVD
• Manufacturer City: SANTA FE SPGS CA 90670000
• Manufacturer Country: US
• Manufacturer Postal Code: 90670 0000
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VITAERES 320
• Generic Name: 73 CBF
• Product Code: CBF
• Date Received: 2014-05-21
• Model Number: 15C37179
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HYPERBARIC TECHNOLOGIES
• Manufacturer Address: 1 SAM STRATON RD AMSTERDAM NY 12010 US 12010

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-05-21