BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION EXPRESSION MRI PATIENT MONITORING SYSTEM

    MDR report key: 2093075 · Received April 14, 2011

    Report

    Report Number
    1051786-2011-00003
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Report Date
    March 18, 2011
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K090785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF THERE WERE A RECURRENCE OF A WHEEL/CASTER FALLING OFF OF THE DEVICE, THIS COULD LEAD TO THE DEVICE HITTING A PATIENT OR STAFF MEMBER AND COULD CAUSE A SERIOUS INJURY. A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE USER FACILITY, HE VERIFIED THAT THE CASTER WAS NOT ASSOCIATED WITH THE DEVICE AS EXPECTED, AND HE REASSEMBLED THE DEVICE AS ILLUSTRATED IN THE CUSTOMER SERVICING DOCUMENTS (SERVICE BULLETIN). THE DEVICE MANUFACTURER IS CURRENTLY INVESTIGATING THIS REPORT FURTHER AND WILL FILE A FINAL REPORT ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE USER REPORTED THAT A REAR WHEEL/CASTER FELL OFF THE DEVICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORATION EXPRESSION MRI PATIENT MONITORING SYSTEM MWI INVIVO CORPORATION 865214

    Patients

    Seq Age Sex Outcome Treatment
    1