BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VC10 PUMP, 115V

    MDR report key: 23184164 · Received September 30, 2025

    Report

    Report Number
    3011050570-2025-01116
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    August 29, 2025
    Report Date
    March 11, 2026
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HHK
    PMA / PMN Number
    K171440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. THE DEVICE WAS NOT RETURNED FOR INSPECTION AND THE CUSTOMER'S ALLEGATION WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION A DEFINITIVE ROOT CAUSE FOR THE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SUBJECT DEVICE HAD MAXIMUM VACUUM LEVEL. THE EVENT OCCURRED DURING SETUP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1838201 VC10 PUMP, 115V VC10 PUMP, 115V HHK GYRUS ACMI, INC. VC-10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown