BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7341064 · Received March 15, 2018

    Report

    Report Number
    3009185973-2018-00081
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    October 18, 2017
    Report Date
    March 15, 2018
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONNECTION ISSUES OBSERVED ARE DUE TO AN INCORRECT BOOT SEQUENCE OF THE CONTROLLER DUE TO A SOFTWARE BUG. NOTE: THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K151359.

    Description of Event or Problem · 1

    A DISTRIBUTOR STATED THAT HE HAD AN UNRECOVERABLE ERROR WHEN HE FIRST STARTED THE SYSTEM PRIOR TO A CASE ON (B)(6) 2017. HE REBOOTED THE SYSTEM AND TRIED AGAIN WITH SUCCESS. ACCORDING TO HIM, THE CASE PROCEEDED AS PLANNED WITHOUT ANY ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186702 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1 3.1.0.1266

    Patients

    Seq Age Sex Outcome Treatment
    1