SECHRIST INDUSTRIES INC.
Received Feb 13, 2025 · Event occurred Jan 16, 2025
Report 2020676-2025-00005 · MDR key 21377503
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER REPORTED THE EMERGENCY VENT TOGGLE SWITCH IS BARELY RESPONDING. THE ISSUE WAS DISCOVERED DURING DAILY STAR-UP. NO PATIENT INCIDENT WAS REPORTED.
Additional Manufacturer Narrative
THIS REPORT IS BASED SOLELY ON THE CUSTOMER'S REPORTED ISSUE. THE DEVICE IS PENDING SERVICE/REPAIR. 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 FILE NO. (B)(4).