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

Model Number 3600E

Device Problems Device Reprocessing Problem (1091); Complete Blockage (1094); Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

Event Date 08/11/2017

Event Type  malfunction  

Event Description

During testing of the hyperbaric chamber, it was noted that the chamber was exhibiting erratic flow during the initial stages of compression until the chamber was up to pressure.In addition, when the user tried to initiate an emergency decompression, the chamber was slow to decompress.Inspection by the manufacturer rep noted excessive clogging of the chamber exhaust filter screen.It was noted that the filter was not completely removed and cleaned on both sides during the standard semi-annual chamber inspection.Biomedical reviewed incident and implemented an immediate change in the process of cleaning the exhaust filters.Biomedical changed the process to include complete removal and cleaning of the main exhaust filter screen.Biomedical also in consultation with the manufacturer on the filter screen size to determine whether or not the fine mesh screens are appropriate for he increased flow in theses larger chambers.Biomedical to increase monitoring of these filters to determine level of clogging in-between inspections.Manufacturer response for hyperbaric chamber, (brand not provided) (per site reporter).Manufacturer reported condition of filter and is consulting with in-house biomedical on corrective action.In-house cleaning procedure implemented to prevent future occurrence.

• Brand Name: SECHRIST 3600E/ER MONOPLACE HYPERBARIC CHAMBER
• Type of Device: CHAMBER, HYPERBARIC
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma ave; anaheim CA 92807
• MDR Report Key: 6812617
• MDR Text Key: 83360372
• Report Number: 6812617
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 3600E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2017
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1