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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES. INC. SECHRIST LOW FLOW OXYGENATOR

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SECHRIST INDUSTRIES. INC. SECHRIST LOW FLOW OXYGENATOR Back to Search Results
Model Number 20400
Device Problem Inaccurate Delivery (2339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
This report is based solely on the customer's medwatch report. Correction to user's facility medsun medwatch model # from 3500 to 20400. Review of the device history records show ' mixer model 20400 s. N. (b)(4) was manufactured on 1/06/2005. A review of the device history record (dhr) found no non-conformance that could cause or contribute to the reported issue. A search of the service records show that the unit has not been back to sechrist every two years for mandatory overhaul/service.
 
Event Description
Information received from a user facility medwatch report # (b)(4) was received on (b)(6) 2019 from fda - "cardiopulmonary bypass circuit wasn't oxygenating and the problem was eventually traced back to the blender not functioning properly. It was set to 100% oxygen with a flow over ten as was unable to deliver oxygen. An oxygen tank was brought in and was able to oxygenate when connected directly to the oxygenator. Sales rep from a company that we are contracted with to support this product were on site to test the device. They agreed device was not supplying oxygen(their sensor readings were 21%). The rep noted that one of the two screws for the dial on the control knob was loose. He tightened the screw and the device worked - delivering close to 100% 02".
 
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Brand NameSECHRIST LOW FLOW OXYGENATOR
Type of DeviceLOW FLOW OXYGENATOR
Manufacturer (Section D)
SECHRIST INDUSTRIES. INC.
4225 e. la palma avenue
anaheim, ca 92807
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC.
4224 e. la palma avenue
anaheim CA 92807
Manufacturer Contact
majid mashayekh
4224 e. la palma avenue
anaheim, CA 92807
7145798309
MDR Report Key8609201
MDR Text Key146374215
Report Number2020676-2019-00010
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 Other Health Care Professional
Type of Report Initial
Report Date 04/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20400
Device Catalogue Number20400
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/06/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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