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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. 3500CP-G RESPIRATORY MIXER, PRODUCT CODE: DTZ

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SECHRIST INDUSTRIES, INC. 3500CP-G RESPIRATORY MIXER, PRODUCT CODE: DTZ Back to Search Results
Device Problem Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/20/2017
Event Type  malfunction  
Manufacturer Narrative
Several attempts were made to retrieve the mixer for an evaluation and the product was not returned to sechrist. A device history review was performed (dhr) mixer 3500cp-g, serial number (b)(4), was manufactured on 10/23/2007. There is no indication that there were any relevant discrepancies during manufacturing. A review of the device history record (dhr) did not find any non-conformance that could cause or contribute to the reported issue.
 
Manufacturer Narrative
The unit has not been returned for an evaluation. Should the unit be returned and evaluated a follow up report will be submitted.
 
Event Description
It was reported that respiratory mixer was part of their heart lung machine during procedure and when the respiratory mixer was used, the mixer did not give any output and the blood was not oxygenated. No reported injuries.
 
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Brand Name3500CP-G
Type of DeviceRESPIRATORY MIXER, PRODUCT CODE: DTZ
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
victor arellano
4225 e. la palma avenue
anaheim, CA 92807
MDR Report Key6603710
MDR Text Key209341147
Report Number2020676-2017-00014
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeTZ
PMA/PMN Number
K023745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/23/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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