SECHRIST INDUSTRIES, INC. MONOPLACE HYPERBARIC CHAMBER - MODEL 4100H/HRCHAMBER
Received Jan 30, 2023 · Event occurred Jan 25, 2023
Report 2020676-2023-00002 · MDR key 16269308
Device
Generic name
Chamber, Hyperbaric
Manufacturer
Sechrist Industries, Inc.Model number
4100H/HRCatalog number
4100H/HR
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Ear Pain
- Ear Pain
Narrative
Additional Manufacturer Narrative
THIS REPORT IS SOLEY FOR THE REPORTED ISSUE THAT A PATIENT EXPERIENCED A BAROTRAUMA DURING TREATMENT. UPON INSPECTION OF CHAMBER, SECHRIST TRAINED TECHNICIAN COULD NOT REPLICATE THE REPORTED FAILURE. THE CHAMBER TESTING REVEALED THAT THE CHAMBER IS FUNCTIONING AS INTENDED AND WITHIN ITS SPECIFICATIONS. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE (IFU) 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 ASESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NO. (B)(4).
Description of Event or Problem
DURING TREATMENT, CUSTOMER FOUND THAT THE CHAMBER WAS RUNNING TOO FAST. CAUSED BAROTRAUMA TO PATIENT.