BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIVO CORPORATIN EXPRESSION MRI PATIENT MONITORING SYSTEM

    MDR report key: 3192280 · Received May 30, 2013

    Report

    Report Number
    1051786-2013-00005
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Report Date
    May 3, 2013
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K090785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF THERE WAS A RECURRENCE OF A WHEELCHAIR 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 WHEELCHAIR 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. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE FOUND THE DEVICE TO BE PHYSICALLY DAMAGED AND WAS UNABLE TO MAKE THE NECESSARY REPAIRS IN THE BED. THEREFORE, THE DEVICE WAS RETURNED TO THE MFR FOR EVAL. THE MFR CONFIRMED THAT A CASTER HAD FALLEN OFF AND THAT THE DEVICE WAS PHYSICALLY DAMAGED. THE MFR IMPLEMENTED A MANDATORY FIELD CHANGE ORDER ON THE DEVICE AND FIXED THE PHYSICAL DAMAGE. THE DEVICE IS CURRENTLY BEING FUNCTIONALLY TESTED BY THE MFR AND WILL BE RETURNED TO THE USER UPON COMPLETION. IT IS UNK HOW THE BASE BECAME DAMAGED BUT IT IS KNOWN THAT THE DAMAGE OCCURRED PRIOR TO SHIPMENT OF THE DEVICE TO THE MFR AS NOTED BY THE FSE. IT IS ALSO KNOWN IF THE EVENTS WHICH LEAD TO THE DAMAGE OF THE BASE OF THE DEVICE ALSO CAUSED OR CONTRIBUTED TO THE CASTER DETACHMENT. THEREFORE, WE ARE CONSIDERING THIS TO BE A MALFUNCTION OF THE DEVICE. THE DEVICE MFR'S INVESTIGATION CONCLUDED THAT THE CAUSE OF THE PROBLEM WAS IMPROPER ASSEMBLY OF THE DEVICE'S CASTERS IN THAT THE ASSEMBLER DID NOT TORQUE THE NYLON LOCKING NUT. THE DEVICE MFR HAS ISSUED A MANDATORY FIELD CHANGE ORDER TO CORRECT THIS CONDITION. US FDA WAS NOTIFIED OF THIS ACTION ON OCTOBER 15, 2012. THE FCO WAS ISSUED 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 INJURY DUE TO THIS ISSUE. NO ADD'L INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE USER CLAIMED THAT A CASTER/WHEEL BECAME DETACHED FROM THE DEVICE. THERE WAS NO REPORTED PT OR USER IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239330 INVIVO CORPORATIN EXPRESSION MRI PATIENT MONITORING SYSTEM MWI INVIVO CORPORATION 865214

    Patients

    Seq Age Sex Outcome Treatment
    1