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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 3500 CP-G AIR OXYGEN MIXER

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SECHRIST INDUSTRIES, INC. SECHRIST AIR/OXYGEN MIXER, MODEL 3500CP-G 3500 CP-G AIR OXYGEN MIXER Back to Search Results
Model Number 3500 CP-G
Device Problem Inaccurate Delivery (2339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/30/2019
Event Type  malfunction  
Manufacturer Narrative
Visual inspection of the mixer and flowmeters found that both of the flowmeters were broken at the top. The mixer could not be tested with the customer's returned flowmeters. The customer was contacted and inquired if the unit was damaged before the unit was shipped, the customer reported there was no damage before shipping. The broken flowmeters were due to customer not providing adequate packaging to ensure the mixer would not be damaged during shipping. The overhaul label is missing on the mixer. Qe tested the mixer with a known good flowmeter and it was found that the output would not go above 21. 2%. The f102 knob was loose and rubbing on the mixer body and only one set screw was in the knob. At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the last overhaul of the mixer found no non-conformities and the mixer passed all functional testing. User manual 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.
 
Event Description
During procedure, the perfusionist states the patient's blood started to turn black and they believe that they were not administering 100% oxygen. No patient injury occurred.
 
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Brand NameSECHRIST AIR/OXYGEN MIXER, MODEL 3500CP-G
Type of Device3500 CP-G AIR OXYGEN 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 ave.
anaheim CA 92807
Manufacturer Contact
majid mashayekh
4225 e. la palma ave,
anaheim, CA 92807
7145798309
MDR Report Key9132146
MDR Text Key195272452
Report Number2020676-2019-00017
Device Sequence Number1
Product Code DTZ
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 health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3500 CP-G
Device Catalogue Number3500 CP-G
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2012
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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