BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF UNIT "ESG-400"

    MDR report key: 16211025 · Received January 19, 2023

    Report

    Report Number
    9610773-2023-00281
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 21, 2022
    Report Date
    June 27, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH BERLIN FACILITY
    Product Code
    IYD
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER'S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 3003724334.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS. DURING THE INSPECTION AT RC, IT'S FOUND THAT HIGH VOLTAGE POWER SUPPLY (HVPS) BOARD WAS FAULTY RESULTING IN E433 ERROR. FURTHERMORE, THE SBC IDENTIFIED DAMAGE TO AN UNSPECIFIED SCREW. SINCE STRONG VOLTAGE PEAKS MAY OCCUR AT THE OUTPUT TRANSFORMER OF THE GENERATOR BOARD, WHICH CAN DESTROY THE TRANSFORMER. A DEFECTIVE CABLE CONNECTION FOR THE OUTPUT SIGNAL BETWEEN THE GENERATOR BOARD AND THE RELAY BOARD (TEMPORARY OR PERMANENT ERROR). A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A HF UNIT HAD A E433 ERROR. IT IS UNKNOWN WHEN THE REPORTED ISSUE WAS FOUND. IT WAS REPORTED THAT THE PATIENT WAS NOT UNDER SEDATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203773 HF UNIT "ESG-400" GENERATORS IYD OLYMPUS WINTER & IBE GMBH BERLIN FACILITY WB91051C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown