BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVIVO CORPORATION

    MDR report key: 1550327 · Received December 2, 2009

    Report

    Report Number
    1051786-2009-00019
    Event Type
    Injury
    Date Received
    December 2, 2009
    Report Date
    May 26, 2009
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MFR'S FIELD SERVICE REP (FSE) VISITED THE CUSTOMER SITE TO EVALUATE THE DEVICE. THE FSE WAS ABLE TO DUPLICATE THE REPORTED PROBLEM AND REPLACED THE DEVICE'S POWER SUPPLY PRINTED CIRCUIT BOARD. FOLLOWING REPLACEMENT OF THIS PRINTED CIRCUIT BOARD, THE DEVICE WAS FUNCTIONALLY TESTED PER INTERNAL TEST PROCEDURES AND RETURNED TO SERVICE BY THE USER. SINCE IT WAS REPORTED THAT A PT CODED, WE WILL CONSIDER THE REPORT TO HAVE BEEN A SERIOUS INJURY. THERE WAS NO ALLEGATION AND THERE IS NO INDICATION THAT THE DEVICE WAS A FACTOR IN THE CODE OR IN THE PT'S OUTCOME. THE INDIVIDUAL THAT REPORTED THE EVENT TO THE DEVICE MFR STATED THAT THE MALFUNCTION OF THE MONITOR "MADE NO DIFFERENCE IN THE OUTCOME" OF THE PT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE DEVICE MFR THAT DURING A PT CODE, THE DEVICE WOULD NOT PRODUCE AN NIBP READING. THE USER HAD TO OBTAIN THE NIBP READING ON THE PT USING A STANDARD CUFF AND STETHOSCOPE. THE PT WAS SUCCESSFULLY REVIVED.

    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 Required Intervention