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U.S. Department of Health and Human Services

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

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SECHRIST INDUSTRIES, INC. SECHRIST AIR/OXYGEN MIXER, MODEL 3500CP-G GAS CONTROL UNIT, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 3500CP-G
Device Problem Inaccurate Flow Rate (1249)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/18/2019
Event Type  malfunction  
Manufacturer Narrative
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. Numerous attempts have been made to retrieve more information on the status of the device and no further information has been forthcoming. If more information is received or if device is returned to sechrist a supplemental medwatch report will be sent. (b)(4). Manufacturer references incident number: (b)(4).
 
Event Description
Foreign customer reported that the knob doesn´t respond. When you put it in 1. 0 it gives you 55 % of oxygen. The technical service person was called and the company replaced it with another blender and took it away for the compliance issue. The issue occurred in argentina. This issue occurred in procedure. No patient injury was reported.
 
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Brand NameSECHRIST AIR/OXYGEN MIXER, MODEL 3500CP-G
Type of DeviceGAS CONTROL UNIT, CARDIOPULMONARY BYPASS
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
majid mashayekh
4225 e. la palma ave.
anaheim, CA 92807
7145798309
MDR Report Key9325239
MDR Text Key207981503
Report Number2020676-2019-00022
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,health profession
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2019
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2018
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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