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

Model Number 3600ER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

Sechrist technician was dispatched onsite on 2/26/2016.Technician performed max pressure test, checked/inspected control panel tubings and other components for possible leaks.Performed chamber control system calibration iaw section 11.5 (electronic control module manual).Performed & completed operational/verification.(b)(4) staff and technician ran chamber for 90 minutes w/rs of 1.5 & ps of 2.4 ata, chamber maintained pressure for duration of test.A review of the device history record (dhr) shows no indication that there were any relevant discrepancies during manufacturing and found no nonconformance that could cause or contribute to the reported issue.

Event Description

It was reported that hyperbaric chamber pressure drops from 2.4ata to 2.3ata.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 ; 7145798400
• MDR Report Key: 6393331
• MDR Text Key: 69564737
• Report Number: 2020676-2017-00003
• 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: Other
• Type of Report: Initial
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600ER
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2016
• 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: 76 YR
• Patient Weight: 126