inforMED
MalfunctionCBF

SECHRIST HYPERBARIC OXYGEN CHAMBER MODEL 4100

Received Feb 4, 2023 · Event occurred Jan 17, 2023

Report 2020676-2023-00003 · MDR key 16301300

Device

Generic name

Chamber, Hyperbaric

Model number

4100H/HR

Catalog number

4100H/HR

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

CUSTOMER REPORTED THE MASTER VALVE IS FEELING STICKY AND DOES NOT ALWAYS ALLOW THE EMERGENCY VENT TO FUNCTION PROPERLY. NO PATIENT INCIDENT WAS REPORTED.

Additional Manufacturer Narrative

EVALUATION OF THE CONCERNED DEVICE FOUND THE EMERGENCY VENT BUTTON WOULD NOT FUNCTION PROPERLY BY NOT DECOMPRESSING THE CHAMBER WHEN THE EMERGENCY VENT BUTTON WAS SWITCHED TO EMERGENCY VENT AND ACTIVATED. THE MASTER VALVE WAS REPLACED AND THE CHAMBER WAS TESTED AND VERIFIED TO BE WORKING AS INTENDED. A DHR REVIEW FOUND 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. MANUFACTURERS REFERENCE FILE NUMBER (B)(4).