BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSION MRI PATIENT MONITORING SYSTEM

    MDR report key: 4407878 · Received September 25, 2014

    Report

    Report Number
    1051786-2014-00012
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Report Date
    September 3, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF THERE WAS A RECURRENCE OF A WHEEL/CASTER FALLING OFF THE DEVICE, IT COULD LEAD TO THE DEVICE FALLING OVER AND HITTING A PATIENT 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 PATIENT, MEDICAL INTERVENTION WOULD BE NECESSARY TO PRECLUDE IMPAIRMENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE USER FACILITY. THE FSE CONFIRMED THE REPORTED PROBLEM. TO FIX THE PROBLEM, THE FSE APPLIED LOCITE TO THE CASTER'S BOLT AND RETIGHTENED THE NUT. THE DEVICE WAS THEN FUNCTIONALLY TESTED AND RETURNED TO SERVICE BY THE CUSTOMER. THE DEVICE REMAINS AT THE CUSTOMER SITE. 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 CAN BECOME LOOSE AND FALL OFF AS TE RESULT OF EXTERNAL VIBRATION OR BUMPS. THE CORRECTIVE ACTION FOR THIS ISSUE WAS TO APPLY LOCITE ADHESIVE TO ALL AFFECTED DEVICES. FDA WAS INITIALLY NOTIFIED OF THE FCO ON 8/30/2010. THE 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 03/17/2011. WHEN ASKED ABOUT THE USER FACILITY'S DEVICE, THE FSE THAT IMPLEMENTED THE FCO SAID HE DID NOT REMEMBER ANY DETAILS REGARDING THE FCO WORK ORDER FOR THE USER FACILITY'S DEVICE SPECIFICALLY. THE FSE THAT WAS DISPATCHED TO THE CUSTOMER SITE AFTER IT WAS REPORTED THAT A WHEEL FELL OFF CHECKED ALL OF THE DEVICE'S REMAINING WHEELS AND DETERMINED THAT ONLY THE ONE WHEEL THAT FELL OFF WAS LACKING LOCITE ADHESIVE. ALL OF THE OTHER WHEELS HAD LOCITE ADHESIVE. THIS SUGGESTS THAT, WHEN THE FCO WAS IMPLEMENTED ON THE DEVICE, ONE WHEEL WAS INADVERTENTLY MISSED. THERE IS NO EVIDENCE INDICATING THAT THIS ISSUE HAS OCCURRED WITH OTHER DEVICES ON WHICH THE ORIGINAL FSE HAD IMPLEMENTED THIS FCO. AS CORRECTIVE ACTION, A COMMUNICATION WAS SENT ON 09/24/2014 TO THE ORIGINAL FSE THAT IMPLEMENTED THE FCO ON THE DEVICE AS WELL AS HIS MANAGER. THIS COMMUNICATION REMINDED THEM OF THE IMPORTANCE OF FCOS BEING FULLY IMPLEMENTED PRECISELY AS DOCUMENTED IN THE PROCEDURE. THERE IS NO EVIDENCE INDICATING THAT THE FCO HAS NOT BEEN EFFECTIVE AT CORRECTING THE PROBLEM WITH THE CASTERS. AS A RESULT, NO ADDITIONAL CORRECTIVE ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A RIGHT WHEEL FELL OFF THE DEVICE. THERE WAS NO REPORTED PATIENT OR USER IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599414 EXPRESSION MRI PATIENT MONITORING SYSTEM MWI INVIVO CORPORATION 865214

    Patients

    Seq Age Sex Outcome Treatment
    1