MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. HYPERBARIC CHAMBER

Model Number 4100H/HR

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

Sechrist field service technician straightened out the bracket on the chamber that stops the gurney from traveling into the purge header and repaired the severed emergency vent line and tested the emergency vent function of the chamber which was working in specification.Historical complaint review 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.Note: this report is being made based on the findings that the emergency vent line was damaged and may not be detected by the user during a procedure with a patient.In the event of an emergency the customer would not be aware that the emergency vent function is not working properly.Manufacturer reference file (b)(4).

Event Description

Sechrist field service technician was at the facility performing a preventative maintenance on the chamber and found that the emergency vent on the chamber was severed from the base frame.The technician found the bracket that stops the gurney from traveling into the purge header was bent which caused the damage to the emergency vent line.No patient contact or injury occured.

Manufacturer Narrative

Supplemental required for correction to section g5 pma/510(k) from (b)(4).

Event Description

Supplemental required to correct 510(k) number.

• Brand Name: HYPERBARIC CHAMBER
• Type of Device: HYPERBARIC CHAMBER
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma avenue; anaheim CA 92807
• MDR Report Key: 9112877
• MDR Text Key: 207979523
• Report Number: 2020676-2019-00016
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• PMA/PMN Number: K100268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4100H/HR
• Device Catalogue Number: 4100H/HR
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1