MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. HYPERBARIC CHAMBER 3600E/ER

Model Number 3600E/ER

Device Problem Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

Sechrist technician was dispatched onsite and evaluated decompression and emergency vent on the chamber.Technician found that exhaust screen was dirty, removed screen and chamber decompresses normally.Technician instructed customer to remove, inspect screen and clean out at least once month.A device history review was performed (dhr) chamber 3600e/er serial number (b)(4) was manufactured on 03/12/2006.There is no indication that there were any relevant discrepancies during manufacturing.A review of the device history record (dhr) found no non-conformance that could cause or contribute to the reported issue.

Event Description

Sechrist is submitting this medwatch report in response to medsun report # (b)(4).On (b)(6) 2017 customer reported decompression issues with their hyperbaric chamber 3600e/er.Customer stated that the emergency vent is slow and decompression rate is also slow.

• Brand Name: HYPERBARIC CHAMBER 3600E/ER
• Type of Device: HYPERBARIC CHAMBER 3600E/ER
• 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: majid mashayekh ; 4225 e. la palma avenue; anaheim, CA 92807
• MDR Report Key: 6871400
• MDR Text Key: 87317784
• Report Number: 2020676-2017-00023
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052713
• 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: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600E/ER
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2006
• 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