SECHRIST INDUSTRIES INC.
Received Apr 2, 2025 · Event occurred Mar 11, 2025
Report 2020676-2025-00012 · MDR key 21758643
Device
Product problems
- Fail-Safe Did Not Operate
- Fail-Safe Did Not Operate
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CUSTOMER REPORTED THAT DURING WEEKLY TESTING THE LOCKING PIN DID NOT ENGAGE. NO PATIENT INVOLVEMENT. NO USER INJURY REPORTED. THE CHAMBER HAS NOT BEEN EVALUATED BY A SECHRIST TRAINED TECHNICIAN YET SO SUBMISSION IS BASED ONLY ON THE USER REPORTED ISSUE. ONCE EVALUATION OF CHAMBER HAS BEEN COMPLETED AND THE ROOT CAUSE DETERMINED, THE REPORTED ISSUE WILL BE REVIEWED TO DETERMINE CONFIRMATION STATUS (CONFIRMED/NOT CONFIRMED). AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE (IFU) 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 A FAILURE MODE WILL BE ASSESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NO.: (B)(4).
Description of Event or Problem
AS REPORTED BY THE FACILITY, "DURING WEEKLY CHECK, THE LOCKING PIN DID NOT ENGAGE." NO PATIENT INVOLVEMENT OR USER INJURY REPORTED.