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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. LOW FLOW AIR OXYGEN MIXER; GAS BLENDER
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SECHRIST INDUSTRIES, INC. LOW FLOW AIR OXYGEN MIXER; GAS BLENDER Back to Search Results
Model Number 3500
Device Problems Loose or Intermittent Connection (1371); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2019
Event Type  malfunction  
Event Description
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% o2.
 
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Brand Name
LOW FLOW AIR OXYGEN MIXER
Type of Device
GAS BLENDER
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC.
4225 e la palma ave
anaheim CA 92807
MDR Report Key8498917
MDR Text Key141442107
Report Number8498917
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number3500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/26/2019
Event Location Hospital
Date Report to Manufacturer04/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age28835 DA
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