SECHRIST MNOPLACE HYPERBARIC CHAMBER - MODEL 3300E/ER
Received Jul 25, 2023 · Event occurred Jul 11, 2023
Report 2020676-2023-00014 · MDR key 17393808
Device
Generic name
Chamber, Hyperbaric, Product Code: Cbf, Product Code: Cbf
Manufacturer
Sechrist Industries, Inc.Model number
3300E/ERCatalog number
3300E/ER
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Dyspnea
- Dyspnea
Narrative
Additional Manufacturer Narrative
CUSTOMER IS REPORTING THAT THEY BELIEVE THE CHAMBER IS NOT FUNCTIONING PROPERLY AS THERE HAVE BEEN PATIENT ISSUES WHILE IN THE CHAMBER. A PATIENT INJURY, CHEST TIGHTNESS, WAS REPORTED. AFTER THE CHAMBER WAS EVALUATED BY TRAINED SECHRIST TECHNICIAN, IT WAS DETERMINED THAT THE CHAMBER WAS FUNCTIONING AS INTENDED AND WITHIN ITS SPECIFICATIONS. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. THEREFORE, THE PATIENT INJURY WAS NOT A RESULT OF THE CHAMBER NOT FUNCTIONING PROPERLY. 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 USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE NECESSARY AT THIS TIME. 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 REFERENCE FILE NO.:(B)(4).
Description of Event or Problem
CUSTOMER CONTACTED SECHRIST TO INFORM THAT THE CHAMBER WAS NOT FUNCTIONING AS INTENEDED. THE FACILITY DID REPORT A PATIENT INJURY, CHEST TIGHTNESS, WHILE PATIENT WAS INSIDE CHAMBER.