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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 Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2022
Event Type  malfunction  
Manufacturer Narrative
Photos provided by the customer showed the knob was no longer attached to the mixer. Service records were requested and have not been received. This device is serviced by a 3rd party and will not be returned to sechrist for evaluation. 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 reference file no. (b)(4).
 
Event Description
Customer reported the subject mixer was found with a loose knob and the shaft was probably turned. Consequently the setting of o2 flow does not correspond with the real value. The problem occurred before use and the patient was not involved.
 
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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 Key14877303
MDR Text Key303414284
Report Number2020676-2022-00017
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 Foreign,Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2022
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
Date Manufacturer Received06/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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