BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION

    MDR report key: 2564556 · Received April 26, 2012

    Report

    Report Number
    1051786-2012-00005
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Report Date
    March 29, 2012
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K090785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE USER FACILITY. THE FSE CONFIRMED THE REPORTED PROBLEM. ACCORDING TO THE FSE, HE FOUND THAT THE CASTER HAD LOCTITE ON THE THREAD, BUT THE NUT HAD FALLEN OFF THE CASTER AND THE CASTER HAD FALLEN OFF THE DEVICE. THE FSE REPORTED THAT THE THREAD WAS NOT PHYSICALLY DAMAGED. THE FSE APPLIED MORE LOCTITE TO THE THREAD AND REAPPLIED/TIGHTENED THE NUT TO FIX THE DEVICE. THE DEVICE MANUFACTURER HAD PREVIOUSLY ISSUED A MANDATORY FIELD CHANGE ORDER (FCO) TO CORRECT CERTAIN DEVICES IN THE FIELD WHOSE SERRATED NUTS HOLDING THE WHEEL/CASTER IN PLACE COULD BECOME LOOSE AND FALL OFF AS THE RESULT OF EXTERNAL VIBRATION OR BUMPS. FDA WAS INITIALLY NOTIFIED OF THE FCO ON AUGUST 30, 2010. THE INITIAL INVESTIGATION INTO THIS INCIDENT FOUND THAT THE USER FACILITY'S DEVICE IS LISTED ON THE UNITS AFFECTED LIST FOR THIS FCO. RECORDS FOR THIS FCO SHOW THAT THE FCO WAS IMPLEMENTED ON THIS DEVICE ON (B)(6) 2011. INTERVIEWS CONDUCTED WITH THE FSE CONFIRM THIS FACT. THE FSE CLAIMS THAT, IN (B)(6) 2011, HE APPLIED LOCTITE TO THE DEVICE'S CASTERS PER THE INSTRUCTIONS IN THE FCO. THERE IS NO EVIDENCE THAT THE DEVICE HAD BEEN TAMPERED WITH BY SOMEONE AT THE USER FACILITY. BASED ON THE INITIAL INVESTIGATION CONDUCTED, THE DEVICE MANUFACTURER DOES NOT KNOW HOW THE CASTER BECAME LOOSE AND FELL OFF THE DEVICE. A REVIEW OF CUSTOMER COMPLAINTS FOR THIS DEVICE SHOWED NO OTHER INCIDENCES OF CASTERS FALLING OFF AFTER IMPLEMENTATION OF THE FCO. THEREFORE, THERE IS NO EVIDENCE SUPPORTING THAT THE FCO IS NOT EFFECTIVE AT CORRECTING THE PROBLEM WITH THE CASTERS. THE DEVICE MANUFACTURER IS STILL INVESTIGATING THIS INCIDENT. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE USER STATED THAT THE WHEEL FELL OFF THE DEVICE. THERE WAS NO REPORTED PATIENT OR USER INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORATION MWI INVIVO CORPORATION 865214

    Patients

    Seq Age Sex Outcome Treatment
    1