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

Model Number 3600ER-00

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2016

Event Type  malfunction  

Event Description

Hyperbaric chamber reached set pressure after 25 minutes.One hour into treatment, pressure was not maintained.Pressure dropped and patient was removed from chamber.No patient harm.

• Brand Name: HYPERBARIC CHAMBER
• Type of Device: CHAMBER, HYPERBARIC
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 east la palma ave.; anaheim CA 92807
• MDR Report Key: 6431426
• MDR Text Key: 70774868
• Report Number: 6431426
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3600ER-00
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 121