BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MORTARA

    MDR report key: 6499859 · Received April 14, 2017

    Report

    Report Number
    MW5069143
    Event Type
    Malfunction
    Date Received
    April 14, 2017
    Date of Event
    April 12, 2017
    Report Date
    April 14, 2017
    Manufacturer
    MORTARA INSTRUMENTS, INC.
    Product Code
    IOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NEW MORTARA TREADMILLS STOP SPONTANEOUSLY POSING A HAZARD TO CARDIOPULMONARY REHAB PATIENTS. MORTARA REP NOTIFIED AND STAFF CAME TO INVESTIGATE AND TREADMILLS PUT BACK IN SERVICE. PROBLEM PERSISTS DESPITE MORTARA LOOKING INTO THE MATTER. WE ARE CONCERNED ABOUT THE POTENTIAL HAZARD OF OUR BRAND NEW TREADMILLS STOPPING SPONTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277510 MORTARA TREADMILL IOL MORTARA INSTRUMENTS, INC. TMX58110
    277511 MORTARA TREADMILL IOL MORTARA INSTRUMENTS, INC. TMX58110
    277512 MORTARA TREADMILL IOL MORTARA INSTRUMENTS, INC. TMX58110
    277513 MORTARA TREADMILL IOL MORTARA INSTRUMENTS, INC. TMX58110
    277514 MORTARA TREADMILL IOL MORTARA INSTRUMENTS, INC. TMX58110
    277524 MORTARA TREADMILL IOL MORTARA INSTRUMENTS, INC. TMX58110
    277525 MORTARA TREADMILL IOL MORTARA INSTRUMENTS, INC. TMX58110

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR