SECHRIST INDUSTRIES INC.
Received Jan 8, 2026 · Event occurred Dec 11, 2025
Report 2020676-2026-00001 · MDR key 24010742
Device
Product problems
- No Audible Alarm
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT THE AIR AND OXYGEN ALARM NOT ACTIVE WHEN LOW PRESSURE. NO PATIENT INVOLVEMENT OR INJURY REPORTED.
Additional Manufacturer Narrative
DEVICE WAS EVALUATED BY SECHRIST AND DETERMINED THAT THE REED WAS DEFECTIVE WHICH LED TO THE ALARM NOT SOUNDING PROPERLY. THE REED WAS REPLACED AND THE UNIT WAS TESTED AND FOUND TO BE ALARMING PROPERLY NOW. THE IFU STATES, PRIOR TO EACH CLINICAL USE, THE USER SHALL PERFORM BYPASS ALARM SYSTEM TEST, VERIFY ACCURACY OF O2 AND INSPECT THE REVERSE GAS FLOW. 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).