SECHRIST INDUSTRIES INC.
Received Dec 16, 2024 · Event occurred Nov 18, 2024
Report 2020676-2024-00023 · MDR key 20946259
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BASED ON THE SECHRIST TECHNICAN REPORTED ISSUE DISCOVERED DURING PM SERVICE. CHAMBER HAS NOT BEEN REPAIRED AT THIS TIME AS WAITING FOR FACILITY TO SCHEDULE SERVICE. THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME TO DETERMINE ROOT CAUSE. THE INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS FOR THE SAFE AND EFFECTIVE USE OF THIS DEVICE. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVETHE 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
DURING PM SERVICE BY SI TECHNICIAN, IT WAS DISCOVERED THAT THE EMERGENCY VENT WAS FALLING OUT OF SPECIFICATION AND NEEDS TO BE REPAIRED TO BRING BACK INTO SPECIFICATION.