SECHRIST INDUSTRIES INC
Received Jul 2, 2026 · Event occurred Jun 4, 2026
Report 2020676-2026-00007 · MDR key 25699226
Device
Product problems
- Gradient Increase
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS EVALUATED BY A SECHRIST TRAINED TECHNICIAN. THE RATES OF COMPRESSION WERE FOUND TO BE OUT OF SPECIFICATION. THE DEVICE WAS TESTED FOR LEAKS, AND NONE WERE FOUND. ATTEMPTS TO ADJUST THE RATE VALVE DETERMINED THE VALVE WAS NO LONGER WORKING AS EXPECTED AND WAS REPLACED. AFTER THE RATE VALVE WAS REPLACED, THE FIELD TECHNICIAN VERIFIED THAT THE RATES OF COMPRESSION AND DECOMPRESSION WERE WITHIN SPECIFICATIONS. THE RISK IS MITIGATED TO THE LOWEST REASONABLE LEVEL THROUGH LABELING AND/OR INSTRUCTIONS IN THE USER'S MANUAL. SECHRIST RECOMMENDS COMPLETING DAILY, WEEKLY AND SEMI-ANNUAL PERFORMANCE VERIFICATION ON THE CHAMBER TO DETECT ANY ISSUES AND PRECLUDE THE DEVICE FROM USE. IN INSTANCES WHERE THE CHAMBER IS FOUND TO FUNCTION OUTSIDE OF SPECIFICATION, SECHRIST SHOULD BE IMMEDIATELY NOTIFIED FOR TECHNICAL ASSISTANCE. MANUFACTURER REFERENCE FILE NUMBER: (B)(4).
Description of Event or Problem
CUSTOMER NOTICED THAT CHAMBER S/N (B)(6) WAS ADJUSTED TO RUN FASTER ON ASCENT. PATIENTS ARE REACHING 2.5 ATA IN 5 MINUTES AT A RATE OF ONE. THIS IS MAKING IT DIFFICULT FOR THEM TO CLEAR THEIR EARS, REQUIRING MULTIPLE STOPS AND PATIENTS COMPLAINED OF PAIN IN THE FOREHEAD AS WELL. NO MEDICAL INTERVENTION WAS REPORTED.