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

Model Number 3600ER-00

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2016

Event Type  malfunction  

Event Description

No harm to patient.Patient safely removed from chamber.Chamber#1 s/n 360196 not holding pressure at depth of 2.4 ata/20.58 psig.No system alarm.Only normal sounds that occur during chamber operation.Notified serena group as soon as discrepency discovered.Manager notified.Emergency call placed to sechrist (b)(4).Sechrist to send service technician."out of order" sign placed on chamber.

• Brand Name: SECHRIST INDUSTRIES, INC.
• Type of Device: CHAMBER, HYPERBARIC
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 east la palma ave.; anaheim CA 92807
• MDR Report Key: 6307045
• MDR Text Key: 66690139
• Report Number: 6307045
• 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: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3600ER-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 126