MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. SECHRIST 3300H/HR, MONOPLACE HYPERBARIC CHAMBER; CHAMBER, HYPERBARIC

Model Number 3300H/HR

Device Problem Decrease in Pressure (1490)

Patient Problem No Patient Involvement (2645)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the chamber has not been completed, a supplemental medwatch report will be sent once the evaluation of the chamber has been completed.Complaint review for past twelve months for similar devices, found no similar incidents.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 references incident (b)(4).

Event Description

During weekly pressure test at 30 psi or 3 ata the hbo tech running the chamber heard a loud hissing noise coming from the chamber door region and observed that the chamber pressure started to decrease rapidly followed by a loud pop and total loss of chamber pressure resulting in the door handle moving from 90 degrees to approximately 30 degrees while holding the door closed during the total loss of chamber pressure, along with what appears to be a broken bolt coming from the cam lock protective cover.The following incident did not result in any injuries to patients or by standards.

Event Description

Supplemental medwatch required for product evaluation.

Manufacturer Narrative

Investigation of the returned chamber found the stop pin and groove in swing arm have been damaged, not allowing the cam shaft to rotate to the closed position in the door.Also, observered there is damage to the tip of the 3-way valve and damage to the paint as a result of an incorrectly adjusted adjustment stem.Note: user's manual provides adequate instructions for properly closing and locking of the chamber door.Manufacturer references complaint # (b)(4).

• Brand Name: SECHRIST 3300H/HR, MONOPLACE HYPERBARIC CHAMBER
• Type of Device: CHAMBER, HYPERBARIC
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma avenue; anaheim CA 92807
• MDR Report Key: 9301082
• MDR Text Key: 207985597
• Report Number: 2020676-2019-00020
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• PMA/PMN Number: K140559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3300H/HR
• Device Catalogue Number: 3300H/HR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1