• 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 INC. HYPERBARIC CHAMBER HYPERBARIC CHAMBER 3300H/HR

  • 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 INC. HYPERBARIC CHAMBER HYPERBARIC CHAMBER 3300H/HR Back to Search Results
Model Number 3300H/HR
Device Problem Output Problem
Event Date 08/13/2019
Event Type  Injury  
Manufacturer Narrative

Evaluation found that the rate knob on the shaft had turned a little and was not tight. Confirmed chamber was found to be running at a rate of 1psi below specification. Technician brought the chamber back into specification. Sechrist chamber user's manual states that a chamber compressing/decompressing at a rate slower than specification, allows the patient extra time to acclimate to the pressure resulting in increased time for cavity equalization (ie. Ear pressure). The risk is mitigated to the lowest reasonable level through labeling and/or instructions in the user's manual. Sechrist recommends completing daily, weekly and semi-annual performance verification on the chamber to detect any issues and preclude the device from use. In instances where the chamber is found to function outside of specification, sechrist should be immediately notified for technical assistance. Device history record review of chamber model 3300h/hr sn (b)(4) was manufactured on 07/23/2012. There is no indication that there were any relevant discrepancies during manufacturing. A review of the device history record (dhr) found no non-conformance that could cause or contribute to the reported issue. Sechrist reference incident number (b)(4).

 
Event Description

As customer reported that the patient started having seizure like symptoms during the ascent phase at 1. 6 ata, during that time the treating physician was called to assist the hbo tech and was ordered to continue ascending and remove the patient. Staff stated that the chamber took 12 minutes at 1. 6 psi to open the door and remove the patient. Clinic would like timing checked on chamber to see if it is in specification. Patient was examined by the er physician and the diagnoses was patient was having elevated st waves via an ekg and a myocardial infarction. The patient was admitted to the hospital and was being followed up for cardiac intervention and stent placement. Additional information was received to sechrist from facility's clinical hbo tech, who stated that the patient had a stent placed in the cath lab and was discharged from the hospital in stable condition and was cleared to return to hbo. The patient was returned back to hbo for treatments without issue.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHYPERBARIC CHAMBER
Type of DeviceHYPERBARIC CHAMBER 3300H/HR
Manufacturer (Section D)
SECHRIST INDUSTRIES INC.
4225 e. la palma avenue
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 Key8993289
Report Number2020676-2019-00013
Device Sequence Number1
Product CodeCBF
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3300H/HR
Device Catalogue Number3300H/HR
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 Received08/13/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/23/2012
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: 09/11/2019 Patient Sequence Number: 1
-
-