SECHRIST INDUSTRIES, INC.
Received Sep 25, 2025 · Event occurred Aug 27, 2025
Report 2020676-2025-00023 · MDR key 23147504
Device
Product problems
- Protective Measures Problem
- Protective Measures Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING REPAIR OF SECHRIST MONOPLACE HYPERBARIC CHAMBER BY SECHRIST INDUSTRIES TRAINED TECHICIAN, IT WAS DISCOVERED THAT THE EMERGENCY DECOMPRESSION WAS OUT OF SPECIFICATION.
Additional Manufacturer Narrative
SECHRIST INDUSTRIES TECHNICIAN TROUBLE SHOOTING OF ISSUE RESULTED IN REPLACING FLOW RESTRICTOR ORIFICE. AFTER REPLACING, THE EMERGENCY VENT TOGGLE SWITCH WAS TESTED AND VERIFIED TO BE EMERGENCY VENTING WITHIN SPECIFICATION. NORMAL WEAR AND TEAR OF COMPONENT ATTRIBUTTED TO THE REPORTED ISSUE AS THE CHAMBER IS OVER TWELVE (12) YEARS OLD. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED ISSUE, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE.THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER'S REFERENCE NO.: (B)(4).