BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON

    MDR report key: 11686561 · Received April 19, 2021

    Report

    Report Number
    1825014-2021-00009
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    February 18, 2021
    Report Date
    April 19, 2021
    Manufacturer
    SAKURA SEIKI, CO., LTD.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO THE SKYTRON TECHNICAL SERVICES DEPARTMENT ON 2/18/2021 THAT A 215SG MODEL STERILIZER EXPERIENCED A THERMAL EVENT. IT WAS DETERMINED THAT THE THERMAL EVENT WAS THE RESULT OF A SHORT-CIRCUITED RELAY BOARD DUE TO A FAILURE OF A SOLENOID VALVE. SINCE 2016, THERE HAVE BEEN THREE SEPERATE OCCURENCES OF SERVICE REQUESTS DUE TO A FAULT IN THE DEVICE. AT THIS TIME THE INVESTIGATION IS STILL UNDERWAY. THE FAILED SOLENOID VALVE AND RELAY BOARD ARE IN THE PROCESS OF BEING SHIPPED TO (B)(4) FOR EVALUATION.

    Description of Event or Problem · 0

    A 215SG STERILIZER MODEL EXPERIENCED A THERMAL EVENT AS A RESULT OF SHORT-CIRCUITED RELAY BOARD DUE TO A SOLENOID VALVE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588759 SKYTRON INTEGRITY 215SG 208R RECESSED FLE SAKURA SEIKI, CO., LTD. ASSV-AB09-208R

    Patients

    Seq Age Sex Outcome Treatment
    1