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

Model Number 3600E

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

On 4/21/2016 a sechrist technician was dispatched onsite.Technician verified control system regulator set to 40.0psi, checked timing and found it was out of specification.Technician replaced i/p regulator and chamber performed as designed.This report is in response to (b)(4) that sechrist received on 3/27/2017.The chamber is designed to fail in safe state.Sechrist electronic control module configuration & diagnostics manual, section 8.12.Category 11 - system errors and alarms, page 20 of 80 states: the "safe state/inoperative" condition is caused by critical system error or an operating condition that renders unsafe.When one or both of the mcus do not respond to the external watchdog timer, the watchdog timer will activate the safety solenoid to drive the chamber into the "safe state" mode.

Event Description

On (b)(6) 2016 customer stated that the chamber is not maintaining set pressure.Chamber is also compressing slow.Actual time to 2.4ata is 25 minutes at rate of 1.5psi/min.No patient injury was reported.

• Brand Name: HYPERBARIC CHAMBER
• Type of Device: CHAMBER, HYPERBARIC
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES, INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer Contact: victor arellano ; 4225 e. la palma avenue; anaheim, CA 92807
• MDR Report Key: 6491007
• MDR Text Key: 72812509
• Report Number: 2020676-2017-00005
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• 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
• Patient Age: 60 YR
• Patient Weight: 121