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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 LOW FLOW GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

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SECHRIST INDUSTRIES, INC SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G LOW FLOW 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 03/09/2020
Event Type  malfunction  
Manufacturer Narrative
This report is based solely on the customer reported issue. The device was requested to be returned and has not been received for evaluation. A service history review, of this customer, for this device, was performed and found no similar complaints for this device. 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 # (b)(4).
 
Event Description
Customer reported the mixer is displaying "low oxygen supply" error message. No patient incident was reported. The issue was discovered during set-up. Customer added the epgs was unable to be calibrated. It was then observed that no gas was flowing from the unit. Observed "low o2 alarm". Technician was able to manually adjust the oxygen (o2) and breathable air nitrogen (n2), oxygen (o2), carbon dioxide (co2). Observed "low o2 alarm". Concluded there is still some type of blockage in the sechrist blender with slide knob.
 
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Brand NameSECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G LOW FLOW
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 Key10736699
MDR Text Key213189650
Report Number2020676-2020-00017
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K023745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 10/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2020
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 Received10/01/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/26/2019
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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