MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC SECHRIST HBO CHMBER,32IN,PNMTC,ENGLISH,BLUE MODEL 3200; CHAMBER, HYPERBARIC

Model Number 3200/R

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

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Chamber was fully inspected and tested to factory specifications.Chamber passed full performance verification testing and was placed back into service.Customer added, the patient was suffering from peripheral vascular disease, and was being treated for critical limp ischemia and has a history of low spo2 saturations.The same patient experienced confinement anxiety and shortness of breath during a second treatment.At which time, a different supervising physician ordered upon removal from the chamber, a full cardiac and pulmonary work up to check for cardiac arrest and pneumothorax via ekg and chest x-ray.Tests ruled out both cardiac arrest and pneumothorax.It was determined that the patient also has confinement anxiety which lead to the shortness of breath leading to desaturation, once the patient was removed and given supplemental o2 via nasal cannula at 4ltr's the patients saturation returned to 100%.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

Customer reported during patient treatment, patient reported having chest pain during and was removed from the chamber.Once the patient was removed his spo2 level was at 86 percent.Patient was given 2l by nasal cannula and spo2 increased to 100 percent.Medical director is concerned that chamber is malfunctioning and wants chamber inspected, before resuming service with this chamber.

• Brand Name: SECHRIST HBO CHMBER,32IN,PNMTC,ENGLISH,BLUE MODEL 3200
• Type of Device: CHAMBER, HYPERBARIC
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES, INC; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma ave.; anaheim, CA 92807 ; 7145798309
• MDR Report Key: 10741856
• MDR Text Key: 213250356
• Report Number: 2020676-2020-00018
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2007
• 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): Required Intervention