BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATION EXPRESSION MRI PATIENT MONITORING SYSTEM

    MDR report key: 2240822 · Received August 8, 2011

    Report

    Report Number
    1051786-2011-00006
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Report Date
    July 5, 2011
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K090785
    Removal / Correction Number
    NOT YET AVAILABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF THERE WAS 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 (FSE) WAS DISPATCHED TO EVALUATE THE DEVICE AND VERIFIED THE REPORTED PROBLEM. THE FSE REMOUNTED THE CASTER THAT HAD FALLEN OFF WITH RED LOCTITE AND A NEW NUT. THE NUTS FROM THE OTHER THREE CASTERS WERE REMOVED, RED LOCTITE WAS APPLIED AND THE NUTS REINSTALLED. ALL REPAIR ACTIVITIES WERE PERFORMED AS ILLUSTRATED IN THE MANDATORY FIELD CHANGE ORDER (FCO), WHICH WAS PREVIOUSLY ISSUED TO CORRECT DEVICES IN THE FIELD. THE FCO WAS ISSUED PRIOR TO THE OCCURRENCE OF THE EVENT OUTLINED THIS REPORT. US FDA WAS NOTIFIED OF THE FCO ON (B)(6) 2010. THE SERRATED NUT HOLDING THE CASTER IN PLACE CAN WORK ITS WAY LOOSE AND SPIN OFF THE SHAFT OF THE CASTER (DUE TO EXTERNAL VIBRATION OR BUMPS), ALLOWING THE CASTER TO EVENTUALLY BECOME DETACHED FROM THE CART. THE MOST COMMON WAY TO PREVENT THIS FROM HAPPENING HAS BEEN THE USE OF LOCTITE OR PATCHLOCK HARDWARE ON CRITICAL MECHANICAL ATTACHMENTS. PREDICATE DEVICES DESIGNED BY THE DEVICE MANUFACTURER USED LOCTITE FOR THIS PURPOSE, BUT A DECISION WAS MADE LATE IN THE DESIGN PROCESS TO REMOVE LOCTITE IN THIS DEVICE'S ASSEMBLY PROCEDURE AS A DESIGN FOR MANUFACTURE IMPROVEMENT. TO CORRECT THE ISSUE, RED LOCTITE WAS ADDED BACK INTO THE DEVICE'S ASSEMBLY PROCEDURE. 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 SALES REPRESENTATIVE REPORTED THAT A WHEEL/CASTER FELL OFF HIS DEMONSTRATION 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