• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES HYPERBARIC CHAMBER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SECHRIST INDUSTRIES HYPERBARIC CHAMBER Back to Search Results
Device Problem No Apparent Adverse Event
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHYPERBARIC CHAMBER
Type of DeviceHYPERBARIC 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 Key7853825
Report Number2020676-2018-00015
Device Sequence Number1
Product CodeCBF
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 Received09/06/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/06/2018 Patient Sequence Number: 1
-
-