inforMED
MalfunctionCBF

SECHRIST MONOPLACE HYPERBARIC CHAMBER-MODEL 3600H/HR

Received Oct 30, 2023 · Event occurred Oct 10, 2023

Report 2020676-2023-00019 · MDR key 18031058

Device

Generic name

Chamber, Hyperbric, Product Code: Cbf

Model number

3600H/HR

Catalog number

3600H/HR

Product problems

  • Use of Device Problem
  • Use of Device Problem

Patient

Unknown

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

Narrative

Additional Manufacturer Narrative

CUSTOMER REPORTED THAT THE CHAMBER DOOR OPENED AT 30 PSI DURING WEEKLY PRESSURE TEST. NO PATIENT WAS INVOLVED AND NO USER INJURY WAS REPORTED. CHAMBER WAS EVALUATED BY SECHRIST TRAINED TECHNICIAN AND FOUND MULTIPLE DAMAGED COMPONENTS CONSISTENT WITH A SUDDEN PRESSURE LOSS, LIKELY FROM NOT CLOSING THE DOOR ALL THE WAY. ROOT CAUSE HAS NOT BEEN DETERMINED. 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).

Description of Event or Problem

CUSTOMER REPORTED THAT THE CHAMBER DOOR OPENED AT 30 PSI DURING WEEKLY PRESSURE TEST. NO PATIENT INVOLVED AND NO USER INJURY REPORTED.

Additional Manufacturer Narrative

THE CHAMBER WAS SERVICED/REPAIRED ON 01/13/2024 BY SECHRIST TRAINED TECHNICIAN UNDER SERVICE ID (B)(4). ROOT CAUSE OF ISSUE HAS BEEN DETERMINED TO BE USER NOT PROPERLY CLOSING THE DOOR COMPLETELY, WHICH LEAD TO THE LOCKING PIN NOT BEING ABLE TO ENGAGE FULLY, THEREBY CAUSING THE DOOR TO OPEN WHEN THE CHAMBER WAS PRESSURIZED. THIS CORRELATES TO THE USER NOT FOLLOWING THE MANUFACTURER'S INSTRUCTIONS. THE USER'S MANUAL INSTRUCTS THE USER TO ONLY PRESSURIZE THE CHAMBER TO IDLE PRESSURE (1.5 PSI) AND CONFIRM THE DOOR LOCKING PIN IS ENGAGED FULLY BY VISUALLY VERIFYING GREEN TIP OF LOCKING PIN IS EXTENDED (VISIBLE), THEN AND ONLY THEN SHOULD THE CHAMBER BE INCREASED TO SET PRESSURE. THIS IS A SUPPLEMENTAL REPORT AS THE INTIAL REPORT DID NOT STATE A ROOT CAUSE AS THE DEVICE WAS YET TO BE REPAIRED/SERVICED AT THAT TIME.