BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES INC.

    MDR report key: 20571712 · Received October 30, 2024

    Report

    Report Number
    2020676-2024-00019
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 2, 2024
    Report Date
    October 30, 2024
    Manufacturer
    SECHRIST INDUSTRIES INC.
    Product Code
    BZR
    UDI-DI
    00899660002345
    PMA / PMN Number
    K992503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT (SN (B)(6)) WAS RETURNED TO SECHRIST FOR EVALUATION. THIS UNIT WAS MANUFACTURED IN 2017. THE EVALUATION DISCOVERED THAT THE O-RING FOR THE REED CAP OF THE ALARM MODULE WAS FOLDED UNDER THE REED CAP. THE CAUSE OF THIS OCCURRING COULD NOT BE DETERMINED. THE DEVICE IN QUESTION WAS OVERHAULED BY (B)(4) ON 09/05/2024. AFTER OVERHAUL OF ANY DEVICE, THE UNIT IS TESTED TO VERIFY IT FUNCTIONS ACCORDING TO ITS SPECIFICATIONS. REVIEW OF THE SERVICE RECORDS WERE REVIEWED IN REGARDS TO THE ALARMS AND ALL THE ALARMS WERE VERIFIED TO BE FUNCTIONING PRIOR TO THE UNIT BEING RETURNED TO CUSTOMER. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT AND THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED. ALL COMPLAINTS ARE TRENDED 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 IS REPORTING THAT THERE UNIT IS NOT ALARMING. NO PATIENT INVOLVEMENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1960938 SECHRIST INDUSTRIES INC. OXYGEN/AIR BREATHING GAS MIXER, HOSPITAL BZR SECHRIST INDUSTRIES INC. 3500CP-G 00899660002345

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown