MAUDE Adverse Event Report: HYPERBARIC TECHNOLOGIES INC./ OXYHEALTH VITAERIS; PORTABLE HYPERBARIC CHAMBER

Model Number VITAERIS 320

Device Problems Burst Container or Vessel (1074); Torn Material (3024)

Patient Problem Discomfort (2330)

Event Date 12/29/2015

Event Type  Injury  

Event Description

A nurse was treating a patient in a vitaeris 320 hyperbaric chamber.It came time to depressurize the chamber and right after she turned the knob to let the pressure out, the vitaeris 320 hyperbaric chamber exploded causing the zipper to rip off.A white dust blew out everywhere and the patient and nurse were pretty shaken up.

• Brand Name: VITAERIS
• Type of Device: PORTABLE HYPERBARIC CHAMBER
• Manufacturer (Section D): HYPERBARIC TECHNOLOGIES INC./ OXYHEALTH; 10719 norwalk blvd.; santa fe springs CA 90670
• MDR Report Key: 5348134
• MDR Text Key: 35182937
• Report Number: MW5058949
• Device Sequence Number: 1
• Product Code: CBF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VITAERIS 320
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1