• 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. 3200 HYPERBARIC CHAMBER CHAMBER, HYPERBARIC

  • 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. 3200 HYPERBARIC CHAMBER CHAMBER, HYPERBARIC Back to Search Results
Model Number 3200
Event Date 04/03/2012
Event Type  Malfunction  
Event Description

The chamber is compressing faster than specified. At a rate of 1 the chamber is pressurizing a 41 sec/psi. When the pressure rate is set to 3 the compression is at the high end of the specification of 50sec/psi. The technician, stated that he is keeping an eye on the pressure and taking the necessary steps/precautions for patient safety.

 
Manufacturer Narrative

Technician is scheduled for site visit to evaluation and provide service. Reported complaint was found during regularly scheduled testing. No patient involvement when complaint was found. A follow-up submission report of findings will be provided once the evaluation of the device is conducted.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3200 HYPERBARIC CHAMBER
Type of DeviceCHAMBER, HYPERBARIC
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC.
anaheim CA
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC.
4225 east la palma ave.
anaheim CA 92807
Manufacturer Contact
4225 east la palma ave.
anaheim , CA 92807
7145798400
MDR Report Key2566545
Report Number2020676-2012-00017
Device Sequence Number1
Product CodeCBF
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial
Report Date 05/03/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/04/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator
Device MODEL Number3200
Device Catalogue Number3200
Is The Reporter A Health Professional? No
Date Manufacturer Received04/02/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/17/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

-
-