BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVIVO CORPORATION

    MDR report key: 1591096 · Received January 20, 2010

    Report

    Report Number
    1051786-2010-00005
    Event Type
    Injury
    Date Received
    January 20, 2010
    Date of Event
    April 22, 2009
    Report Date
    April 22, 2009
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURER'S FIELD SERVICE REPRESENTATIVE (FSE) VISITED THE CUSTOMER SITE TO EVALUATE THE DEVICE. THE FSE WAS ABLE TO DUPLICATE THE REPORTED PROBLEM AND REPLACED THE DEVICE'S RADIO AS A RESULT OF HIS EVAL. ALTHOUGH THE USER REPORTED A PROBLEM WITH THE NIBP PARAMETER, THE ACTUAL PROBLEM WAS WITH THE DEVICE'S RADIO. THE PROBLEM WITH THE DEVICE'S RADIO CAUSED THE REQUESTED NIBP READING TO NOT BE TRANSMITTED FROM THE DISPLAY MONITOR (WHERE IT IS INITIATED) TO THE BASE MONITOR (WHICH ACTUALLY TAKES THE NIBP READING). FOLLOWING REPLACEMENT OF THE RADIO, THE DEVICE WAS FUNCTIONALLY TESTED PER INTERNAL TEST PROCEDURES AND RETURNED TO SERVICE BY THE USER. WE ARE CONSIDERING THAT THERE WAS A NEED FOR EMERGENT CARE BECAUSE THE PT WAS REPORTED AS HAVING CODED. THEREFORE, THIS IS CONSIDERED AS A SERIOUS INJURY. THE AVAILABLE INFO GIVES NO INDICATION THAT THE INABILITY OF THE USERS TO OPERATE THE NIBP FUNCTION WAS A FACTOR IN THE CODE. IF THIS MALFUNCTION WERE TO RECUR, IT WOULD NOT LEAD TO A SERIOUS INJURY OR DEATH BECAUSE THIS MALFUNCTION WOULD BE OBVIOUS TO THE USER. IF THE MALFUNCTION WERE TO RECUR, THE USER IS LIKELY TO UTILIZE A BACK-UP MONITOR TO PROCEED WITH THE CASE. IF A BACK-UP MONITOR WAS UNAVAILABLE AND LACK OF A BACK-UP MONITOR WAS TO PRECLUDE THE USE OF THE SCANNING DEVICE IN DIAGNOSIS, ALTERNATIVE DIAGNOSTIC METHODS WOULD BE IMPLEMENTED AS WARRANTED FOR THE PT.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THEY HAD A PT CODE AND THE DEVICE'S NIBP PARAMETER DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORATION PRECESS MRI PATIENT MONITORING SYSTEM MWI INVIVO CORPORATION 3160

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention