MAUDE Adverse Event Report: SECHRIST HYPERBARIC OXYGEN CHAMBER; CHAMBER, HYPERBARIC

Model Number 3200/R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Convulsion/Seizure (4406)

Event Type  Injury  

Manufacturer Narrative

This report is based solely on the customer reported issue.Service/repair is pending and has not been completed at this time.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.The instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Uncontrolled seizure disorders has been identified as a possible contraindication and must be carefully weighed by the physician with each patient's unique preexisting condition or concurrent therapies in mind.Manufacturer reference file #(b)(4).

Event Description

Customer reported the medical center had a patient have a seizure very early in their treatment and on their third dive.The date the incident occured was not reported.

Manufacturer Narrative

Performance verification of the device found the device to be in excellent condition and functioning as expected.No functional issues were noted.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 reference file #(b)(4).

Event Description

Supplemental medwatch required for device evaluation.

• Brand Name: SECHRIST HYPERBARIC OXYGEN CHAMBER
• Type of Device: CHAMBER, HYPERBARIC
• MDR Report Key: 12213106
• MDR Text Key: 263079920
• Report Number: 2020676-2021-00018
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• PMA/PMN Number: K950386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3200/R
• Device Catalogue Number: 3200/R
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2006
• 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