BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION

    MDR report key: 4080220 · Received August 19, 2014

    Report

    Report Number
    1051786-2014-00010
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Report Date
    July 21, 2014
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER CLAIMED THAT A FRONT WHEEL CAME OFF THE DEVICE. THERE WAS NO REPORTED PT OR USER IMPACT OR INVOLVEMENT. IF THERE WAS A RECURRENCE OF A WHEEL/CASTER FALLING OFF 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 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. A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE USER FACILITY. THE FSE CONFIRMED THE REPORTED PROBLEM AND ARRANGED FOR THE DEVICE TO BE RETURNED FOR BENCH REPAIR. WHEN THE DEVICE WAS RETURNED TO THE BENCH, IT WAS FOUND TO BE MISSING THE TWO FRONT WHEELS. TO FIX THE PROBLEM, THE FOLLOWING KIT WAS ORDERED AND INSTALLED IN THE DEVICE. (B)(4) (CASTER WHEEL KIT). FOLLOWING INSTALLATION OF THIS KIT, THE DEVICE WAS FUNCTIONALLY TESTED AND RETURNED TO THE USER. PREVIOUS INVESTIGATION INTO THE ISSUE HAD SHOWN THAT THE PROBLEM WAS CAUSED BY INADEQUATE MANUFACTURING ASSEMBLY INSTRUCTIONS TO CORRECT APPLICATION OF LOCTITE PER THE DESIGN INTENT. TO ADDRESS THIS ISSUE WITH DEVICES IN THE FIELD, THE DEVICE MANUFACTURER ISSUED A MANDATORY FIELD CHANGE ORDER (FCO). US FDA WAS INITIALLY NOTIFIED OF THE FCO ON (B)(4) 2010. THIS ACTION WAS THEN EXPANDED TO INCLUDE ADD'L DEVICES IN DISTRIBUTION. US FDA WAS NOTIFIED OF THIS EXPANSION ON (B)(4) 2011. THIS DEVICE WAS INCLUDED IN THE UNITS AFFECTED LIST FOR THIS MANDATORY FCO, BUT THE DEVICE WAS NOT ABLE TO BE LOCATED AND THE FCO WAS NOT IMPLEMENTED ON THE DEVICE. TO IMPROVE THE DESIGN OF THE PRODUCT AND PREVENT RECURRENCE OF THE ISSUE, A NYLON LOCKING NUT WAS IMPLEMENTED IN PRODUCTION IN PLACE OF LOCTITE TO BETTER ENSURE THAT THE NUT DOES NOT COME LOOSE. PRIOR TO THE MARKET RELEASE OF THE PRODUCT, CORRECT APPLICATION OF LOCTITE WAS VERIFIED AS AN ADEQUATE MEANS OF SECURING THE CASTERS. THERE HAVE BEEN NO REPORTS OF DEATHS OR SERIOUS INJURIES DUE TO THIS ISSUE. NO ADD'L INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMED THAT A FRONT WHEEL CAME OFF THE DEVICE. THERE WAS NO REPORTED PT OR USER IMPACT OR INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497031 INVIVO CORPORATION MWI INVIVO CORPORATION 865214

    Patients

    Seq Age Sex Outcome Treatment
    1