BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION MRI PT MONITORING SYSTEM

    MDR report key: 2954282 · Received January 9, 2013

    Report

    Report Number
    1051786-2013-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 10, 2012
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K090785
    Removal / Correction Number
    Z-0106-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF THERE WAS A RECURRENCE OF A WHEEL/CASTER FALLING OFF OF THE DEVICE, IT COULD LEAD TO THE DEVICE FALLING OVER AND HITTING A PT OR STAFF MEMBER, WHICH COULD CAUSE A SERIOUS INJURY. ADDITIONALLY, IF A WHEEL/CASTER WERE TO FALL OFF OF THE DEVICE AND THE DEVICE FALLS AND DISCONNECTS AN ARTERIAL CATHETER (MEASURING INVASIVE BLOOD PRESSURE) FROM A PT, MEDICAL INTERVENTION WOULD BE NECESSARY TO PRECLUDE IMPAIRMENT. THE USER REPORTED THAT THEY WERE ABLE TO PLACE THE WHEEL BOLT BACK IN THE HOLE AT THE BOTTOM OF THE BASE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. BY VISUALLY INSPECTING THE DEVICE, THE FSE CONFIRMED THE REPORTED PROBLEM. THE FSE IMPLEMENTED (B)(4) ON THE DEVICE BY APPLYING LOCTITE TO EACH CASTER BOLT AND RETIGHTENING EACH NUT. THE DEVICE WAS THEN FUNCTIONALLY TESTED AND RETURNED TO SERVICE BY THE USER. THE DEVICE REMAINS AT THE USER FACILITY. THE DEVICE MFR'S INVESTIGATION CONCLUDED THAT THE PROBLEM OCCURRED BECAUSE THE SERRATED NUT HOLDING THE WHEEL/CASTER IN PLACE BECAME LOOSE AND FELL OFF AS THE RESULT OF EXTERNAL VIBRATION OR BUMPS. THE DEVICE MFR HAD PREVIOUSLY ISSUED A MANDATORY FIELD CHANGE ORDER TO CORRECT THIS CONDITION. US FDA WAS INITIALLY NOTIFIED OF THIS ACTION ON (B)(4) 2010. THE (B)(4) WAS ISSUED PRIOR TO THE OCCURRENCE OF THE EVENT OUTLINED IN THIS REPORT AND THE USER FACILITY'S DEVICE HAD NOT RECEIVED THE UPDATE AS OF THE DATE OF THIS EVENT. THERE HAVE BEEN NO REPORTS OF DEATHS OR SERIOUS INJURIES DUE TO THIS ISSUE. NO ADDITIONAL INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE FRONT WHEEL FELL OFF OF THEIR DEVICE AND CAUSED THE DEVICE TO FALL TO THE FLOOR. THERE WAS NO REPORTED PT OR USER IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11266 INVIVO CORPORATION MRI PT MONITORING SYSTEM MWI INVIVO CORPORATION 865214

    Patients

    Seq Age Sex Outcome Treatment
    1