SECHRIST INDUSTRIES INC.
Received May 14, 2025 · Event occurred Apr 8, 2025
Report 2020676-2025-00016 · MDR key 22021871
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Cramp(s) /Muscle Spasm(s)
- Cramp(s) /Muscle Spasm(s)
Narrative
Description of Event or Problem
CUSTOMER REPORTED TO SECHRIST THAT SEVERAL PATIENTS HAVE COMPLAINED OF SEVERE CRAMPING AFTER COMING OUT OF THE CHAMBER. CUSTOMER DID NOT REPORT ANY ISSUES WITH THE CHAMBER. THEY REQUESTED SECHRIST COME OUT AND EVALUATE THE CHAMBER ANYWAY. THEY WERE ALSO GOING TO CONTACT THE SUPPLIER OF THEIR MEDICAL GAS FOR A PURITY REPORT.
Additional Manufacturer Narrative
CUSTOMER CONFIRMED NO ISSUES WITH CHAMBER SO NO NEED FOR SECHRIST TO EVALUATE CHAMBER AS INITIALLY REQUESTED. SECHRIST IS REPORTING BASED ONLY ON THE REPORTED PATIENT INJURY (SEVERE CRAMPING) EVEN THOUGH INJURY HAS BEEN CONFIRMED NOT TO BE A RESULT OF OUR CHAMBER. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, 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 REFERENCE NO. (B)(4).