BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST AIR/OXYGEN GAS BLENDER MODEL UNK

    MDR report key: 16005488 · Received December 19, 2022

    Report

    Report Number
    2020676-2022-00027
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    November 30, 2022
    Report Date
    December 16, 2022
    Manufacturer
    SECHRIST INDUSTRIES, INC
    Product Code
    DTX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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. MIXERS ARE MULTI-USE, SERVICEABLE ITEMS. AS SUCH, IT IS ANTICIPATED THAT THE UNITS MAY OCCASIONALLY REQUIRE REPAIR, AND AS PART OF STANDARD CARE THE MIXER SHOULD BE INSPECTED PRIOR TO USE. IF DAMAGE OR FUNCTIONAL ISSUES ARE NOTED DURING THESE ROUTINE MIXER INSPECTIONS, THE UNIT SHOULD NOT BE PUT INTO USE WITH A PATIENT AND SHOULD BE REPORTED TO SECHRIST FOR SERVICING. 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).

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE ALARM MODULE IS FAULTY (ACOUSTIC ALARM IS NOT RESET WHEN O2 IS CONNECTED AND THEN AIR). FACTORY REPAIR IS REQUIRED. ISSUE WAS FOUND DURING MAINTENANCE. NO PATIENT INCIDENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2125424 SECHRIST AIR/OXYGEN GAS BLENDER MODEL UNK GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTX SECHRIST INDUSTRIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown