MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. CHAMBER, HYPERBARIC; HYPERBARIC MONOPLACE CHAMBER

Model Number 3300H

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2014

Event Type  malfunction  

Event Description

During clinical use the chamber decompressed from 2.0 at to 0 ata in 6.5 minutes.Testing of the chamber was done, by the center staff, after the pt was removed and the failure was duplicated.Info provided by the center states that the pt was not injured.They are reported as doing "fine".

Manufacturer Narrative

The reported complaint that the chamber is decompressing faster than spec was verified.The decompression timing from 2.0 ata to 0 ata in 6.5 minutes could be a potential safety issue if the pt has lung disease and holds their breath.This could result in gas becoming trapped in their chest.The chamber was evaluated by a technician from the mfr.He found that the rate valve ws out of calibration and required an adjustment.A note was included in the report stating that the issue was resolved.The cause of the rate valve going out of spec and increasing the decompression timing is unk.The probable cause is drift.

• Brand Name: CHAMBER, HYPERBARIC
• Type of Device: HYPERBARIC MONOPLACE CHAMBER
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; anaheim CA
• Manufacturer Contact: 4225 east la palma ave.; anaheim, CA 92807 ; 7145798400
• MDR Report Key: 3983290
• MDR Text Key: 4635787
• Report Number: 2020676-2014-00025
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3300H
• Device Catalogue Number: 3300H-01-1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1