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

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

Patient Problems Death (1802); Suffocation (2088)

Event Type  Death  

Event Description

(b)(4).

Manufacturer Narrative

Five samples of the air hose connector (p/n hfc 17612 by colder products co) (identical to the part on #3398) were randomly selected from inventory and performance testing was conducted and all five found to be per specifications.The air hose was attached to a vitaeres 320 hyperbaric chamber and tests were conducted to make the connector fail but the connector remained intact.The only way to make it disconnect other than by hand was to have a stationary blunt object next to the exact center of the push button release and after 3.5 pounds of pressure, it disconnected.We have concluded that given the perfect safety record of over 13 year and (b)(4) chambers using this device, and the extreme unlikelihood of this ever to happen again we feel most confident in its use.The ifus of this product recommend that use of the device include supervision.

• Brand Name: VITAERES 320
• Type of Device: 73CBF
• Manufacturer (Section D): HYPERBARIC TECHNOLOGIES, INC.; one sam stratton rd.; amsterdam NY 12010
• Manufacturer Contact: peter lewis ; one sam stratton rd.; amsterdam, NY 12010 ; 5188423030
• MDR Report Key: 3838678
• MDR Text Key: 19408489
• Report Number: 2438426-2014-00001
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• PMA/PMN Number: K001409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2005
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1