MAUDE Adverse Event Report: SECHRIST INDUSTRIES HYPERBARIC CHAMBER

Device Problem No Apparent Adverse Event (3189)

Patient Problem Death (1802)

Event Date 08/13/2018

Event Type  Death  

Manufacturer Narrative

Hospital instructed that chamber be taken out of service.On (b)(6) 2018, the hospital assigned an independent technician (b)(6) with (b)(4) to inspect the chamber and the chamber was found to meet specification.On august 27, 2018 (b)(4) with sechrist industries, the chamber was tested and performed to manufacturer specifications.A dhr (device history record) review was performed.The chamber, serial number (b)(4), was manufactured on 07/01/2011.There is no indication that there were any relevant discrepancies during manufacturing.A review of the device history record (dhr) found no nonconformance that could cause or contribute to the reported issue.

Event Description

It was reported that patient expired post treatment of hbot (hyperbaric oxygen therapy).Patient was receiving his 14th hbot treatment of 110 minutes and was being treated for a diabetic foot ulcer.Technician operating the chamber noticed the patient was unresponsive and was removed from the chamber, with no respiration post treatment and cpr was initiated by staff.Aed was untilized without shocks being given.Ems responded within 5 minutes and conducted a full code for 50 minutes before patient was pronounced dead.

• Brand Name: HYPERBARIC CHAMBER
• Type of Device: HYPERBARIC CHAMBER
• Manufacturer (Section D): SECHRIST INDUSTRIES; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES; 4225 e. la palma; anaheim 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma; anaheim 92807
• MDR Report Key: 7853825
• MDR Text Key: 119480997
• Report Number: 2020676-2018-00015
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2011
• 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): Death
• Patient Age: 66 YR