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U.S. Department of Health and Human Services

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

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SECHRIST INDUSTRIES, INC. 3500CP-G RESPIRATORY MIXER Back to Search Results
Device Problem Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/23/2017
Event Type  malfunction  
Manufacturer Narrative
Customer returned mixer 3500cp-g for evaluation. The unit was tested and the following observations were made: the unit's water trap has an indentation in the side of it. The fio2 knob does not engage the double needle valve. The fio2 does not climb higher that 21. 1 % o2. The balance baseline reading are out of specification at. 30,. 60, and. 90 fio2. The fio2 knob was checked to see if it has slipped on the shaft. Upon removing the knob there were two (2) distinct marks on the shaft. The shaft was turned to see where the shaft would engage the double needle the adjustment shaft was turned out approximately one (1) turn. The fio2 knob was reinstalled and the unit was retested. The unit when retested with the reset mix fio2 knob tested without any observations. Root cause: the fio2 knob has been reset; there is not enough information to determine by who. Device history review (dhr) was performed. Mixer 3500cp-g serial number (b)(4) was manufactured on 08/11/2016. There is no indication that there were any relevant discrepancies during manufacturing. A review of the device history record (dhr) found no non-conformance that could cause or contribute to the reported issue.
 
Manufacturer Narrative
The unit has not been returned for evaluation. Should the unit be returned and evaluated a follow up report will be submitted. A review of the device history record (dhr) found no non-conformance that could cause or contribute to the reported issue. Mixer 3500cp-g serial number (b)(4) was manufactured on 08/11/2016. There is no indication that there were any relevant discrepancies during manufacturing.
 
Event Description
It was reported that during use of respiratory mixer during an open heart surgery the arterial blood gas showed low oxygen blood. Customer tried adjusting oxygen but still showed low oxygen blood. Customer swapped mixers and the arterial blood gas was normal. No patient injury was reported.
 
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Brand Name3500CP-G
Type of DeviceRESPIRATORY MIXER
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 Key6586807
MDR Text Key249526046
Report Number2020676-2017-00010
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeTH
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 04/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2017
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 Manufacturer07/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2016
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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