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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

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SECHRIST INDUSTRIES, INC SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G GAS CONTROL UNIT, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 3500CP-G
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2021
Event Type  malfunction  
Manufacturer Narrative
This report is based solely on the customer's reported issue. The device is serviced by a 3rd party and not available for return to the manufacturer. Review of dhr for this mixer found no indication that there were any relevant discrepancies during manufacture of the device and no non-conformance that could have caused or contributed to the reported issue. Based on the age of the device the likely cause is normal wear and tear. At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device. Therefore, no corrective or preventative actions are necessary. All complaints are trended and reviewed by management on a monthly basis. As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted. Manufacturer refenced file #(b)(4).
 
Event Description
Customer reported the patient under cec ecls is admitted to intensive care at 9:30 p. M. By the smur (emergency rapid response unit) in (b)(6). On arrival the patient requires an increase in fio2 on the sechrist. However, it is impossible on the latter to make a rotation beyond 80% with the sechrist wheel.
 
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Brand NameSECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G
Type of DeviceGAS CONTROL UNIT, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC
4225 e. la palma ave.
anaheim CA 92807
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC
4225 e. la palma ave.
anaheim CA 92807
Manufacturer Contact
majid mashayekh
4225 e. la palma ave.
anaheim, CA 92807
7145798309
MDR Report Key11646180
MDR Text Key247158553
Report Number2020676-2021-00009
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K023745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3500CP-G
Device Catalogue Number3500CP-G
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 Received03/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/13/2010
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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