MAUDE Adverse Event Report: SECHRIST INDUSTRIES INC. SECHRIST MONOPLACE HYPERBARIC CHAMBER - MODEL 3300HJ; CHAMBER, HYPERBARIC

Model Number 3300HJ

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 01/15/2024

Event Type  Injury  

Manufacturer Narrative

Patient injury was caused by disposable warmer that was attached to patients back.Once in chamber, the warmer slipped down to patient's buttocks.The increased pressure inside the chamber caused the heat from the warmer to intensify which resulted in patient suffering minor burns in that area.Sechrist is reporting soley to report the patient injury.The current device user's manual clearly indicates "heat generating topical pads" as a prohibited item and recommends a patient search be conducted.Facility has been informed of the importance of pre-clinical check of the patient to ensure no prohibited items are being taken into chamber.Prior to incident, facility only required patients to sign waiver saying that they have no prohibited items on their person, in response to incident, facility has implemented new procedure to physically check patient and question patient on the presence of any prohibited items on their person prior to entry into chamber.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).

Event Description

Japanese distributor reported to sechrist the following customer reported incident: when the chamber pressure rose to around 1.8 ata , the patient reported to the operator that her butt was hot.From this event, the patient was reported to have received minor burns.

• Brand Name: SECHRIST MONOPLACE HYPERBARIC CHAMBER - MODEL 3300HJ
• Type of Device: CHAMBER, HYPERBARIC
• Manufacturer (Section D): SECHRIST INDUSTRIES INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma avenue; anaheim, CA 92807 ; 7145798400
• MDR Report Key: 18754657
• MDR Text Key: 335933557
• Report Number: 2020676-2024-00005
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 3300HJ
• Device Catalogue Number: 3300HJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other