• 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. 3500 CP-G AIR OXYGEN MIXER OXYGENATOR, CARDIOPULMONARY BYPASS

  • 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. 3500 CP-G AIR OXYGEN MIXER OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Device Operational Issue (2914)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 02/01/2018
Event Type  malfunction  
Manufacturer Narrative
The 3500cp-g mixer, serial number (b)(4), was returned due to the reported issue of the mixer unit failing "to oxygenate and flow co2"during patient use. No patient injury. The device did not oxygenate and flow gas due to improper usage by the user. The 3500cp-g mixer is a "precision gas mixing device intended for use with medical breathing air and medical breathing oxygen only" per the user's manual. Also stated in the user's manual is the "user of the sechirst air/oxygen mixer shall have sole responsibility for any malfunction, which results from improper usage. The failures observed during full testing per doc. (b)(4) recorded in the product evaluation section of this report are due to the failure of the device not being overhauled per the manufacturer's recommended interval of every 2 years. A dhr (device history review) was performed. The 3500cp-g mixer, serial number (b)(4), was manufactured on 6/11/2015. There is no indication that there were any relevant discrepancies during manufacturing. Device history record (dhr) did not find any non-conformance that could cause or contribute to the reported issue.
 
Event Description
It was reported that mixer did not oxygenate and flow co2 during use. No patient injury was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3500 CP-G AIR OXYGEN MIXER
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC.
4225 e. la palma avenue
anaheim CA 92807
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC.
4225 e. la palma avenue
anaheim CA 92807
Manufacturer Contact
majid mashayekh
4225 e. la palma avenue
anaheim, CA 92807
MDR Report Key7329454
MDR Text Key102202922
Report Number2020676-2018-00004
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K023745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 02/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-