BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES INC.

    MDR report key: 20904359 · Received December 11, 2024

    Report

    Report Number
    2020676-2024-00022
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    November 12, 2024
    Report Date
    December 10, 2024
    Manufacturer
    SECHRIST INDUSTRIES INC.
    Product Code
    BZR
    UDI-DI
    00899660002796
    PMA / PMN Number
    K992503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ISSUE DISCOVERED DURING PM SERVICE BY THIRD PARTY. CUSTOMER DID NOT REPORT ISSUE TO OUR EU DISTRIBUTOR. NO PATIENT INVOLVEMENT OR INJURY REPORTED. NEITHER CUSTOMER OR DISTRIBUTOR REPORTED TO FDA ACCORDING TO THE INFORMATION WE HAVE AT THIS TIME. DEVICE IN QUESTION WILL NOT BE EVALUATED BY SECHRIST AS DISTRIBUTOR WILL EVALUATE. AT THIS TIME, THE REPORT IS BASED ON THE INFORMATION WE HAVE. WE HAVE REQUESTED MORE INFORMATION FROM OUR DISTRIBUTOR IN REGARD TO SERVICE RECORDS AND DISPOSITION OF THE DEVICE IN QUESTION. MANUFACTURER REFERENCE FILE NO. (B)(4).

    Description of Event or Problem · 0

    DURING PM SERVICE BY A THIRD PARTY, THE MIXER WAS DISCOVERED TO BE CONTAMINATED WITH BLOOD ON THE INSIDE AND THEREFORE DETERMINED TO BE DEFECTIVE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437950 SECHRIST INDUSTRIES INC. MIXER, GENERAL, GERMAN BZR SECHRIST INDUSTRIES INC. 3500CP-G4 00899660002796

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown