inforMED
MalfunctionCBF

SECHRIST MONOPLACE HYPERBARIC CHAMBER-MODEL 3600H/HR

Received Jun 30, 2023 · Event occurred Jun 20, 2023

Report 2020676-2023-00012 · MDR key 17243321

Device

Generic name

Chamber, Hyperbaric, Product Code: Cbf

Model number

3600H/HR

Catalog number

3600H/HR

Product problems

  • Activation, Positioning or Separation Problem
  • Activation, Positioning or Separation Problem

Patient

Unknown

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

Narrative

Description of Event or Problem

CUSTOMER IS STATING THAT THE EMERGENCY VENT BUTTON ON THE CHAMBER IS NOT WORKING WHEN USED FOR TESTING.

Additional Manufacturer Narrative

CUSTOMER IS STATING THAT THE EMERGENCY VENT BUTTON ON THE CHAMBER IS NOT WORKING WHEN USED FOR TESTING. NO PATIENT INCIDENT WAS REPORTED. AFTER CHAMBER EVALUATED BY TRAINED SECHRIST TECHNICIAN, IT WAS DISCOVERED THAT THE EMERGENCY VENT BUTTON IS FUNCTIONING AS INTENDED AS WELL AS THE REST OF THE CHAMBER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. THE CHAMBER IS FUNCTIONING AS INTENDED AND IS IN SPECIFICATIONS. THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE NECESSARY AT THIS TIME. 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).