SECHRIST INDUSTRIES INC.
Received Apr 18, 2025 · Event occurred Mar 25, 2025
Report 2020676-2025-00014 · MDR key 21868147
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
SECHRIST INDUSTRIES TECHNICIAN TROUBLE SHOOTING OF ISSUE RESULTED IN REPLACING CLIPPER VALVE OF THE EMERGENCY VENT BUTTON. AFTER REPLACING, THE EMERGENCY VENT BUTTON WAS TESTED AND VERIFIED TO BE WORKING AS INTENDED. NORMAL WEAR AND TEAR OF THIS PART ATTRIBUTTED TO THE REPORTED ISSUE AS THE CHAMBER IS OVER FIFTEEN (15) YEARS OLD. 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).
Description of Event or Problem
DURING PM SERVICE, SECHRIST INDUSTRIES TECHNICIAN DISCOVERED THAT THE EMERGENCY VENT BUTTON WAS NOT WORKING PROPERLY. FACILITY NEVER REPORTED TO SECHRIST. EMERGENCY VENT BUTTON WOULD ONLY WORK WHEN PUSH EM VENT BUTTON AND TURN MASTER VALVE TO EM VENT POSITION.