BEUDAMED
    FDA Adverse Event Death Summary report: N

    INVIVO CORPORATION

    MDR report key: 1534686 · Received November 18, 2009

    Report

    Report Number
    1051786-2009-00014
    Event Type
    Death
    Date Received
    November 18, 2009
    Date of Event
    January 9, 2009
    Report Date
    January 12, 2009
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ALTHOUGH THE USER REPORTED A PATIENT DEATH, THE USER STATED THAT THE PATIENT MONITORING SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. THE PATIENT MONITORING SYSTEM CORRECTLY ALERTED THE USER TO A CHANGE IN THE PATIENT'S CONDITION WHEN THE PATIENT CODED, THERE WAS NO DELAY IN TREATMENT OF THE PATIENT AND THE PATIENT WAS SUCCESSFULLY REVIVED. THE USER REPORTED THAT THE PATIENT LATER EXPIRED IN THE INTENSIVE CARE UNIT. THE USER INITIALLY CALLED THE DEVICE MANUFACTURER TO OBTAIN ASSISTANCE WITH PRINTING DATA FROM THE DEVICE DURING THE TIME OF THE PATIENT'S CODE. THE USER REPORTED THAT THEY WERE EXPERIENCING PROBLEMS OBTAINING THE PRINTOUTS BECAUSE THE DISPLAY UNIT COMMUNICATING WITH THE PROCESSING UNIT DURING THE EVENT DID NOT HAVE THE OPTIONAL RECORDER INSTALLED. THE DEVICE MANUFACTURER SUGGESTED THAT THE USER UTILIZE A DIGITAL CAMERA TO TAKE PICTURES OF THE SCREENS OF INTEREST SINCE THE DEVICE COULD NOT PRINT THE PATIENT'S DATA WITHOUT A RECORDER INSTALLED IN THE DEVICE. SINCE THE USER DID NOT PURCHASE THE OPTIONAL RECORDER FOR USE WITH THE DEVICE, THE DEVICE MANUFACTURER DOES NOT CONSIDER THIS TO BE A MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT CODED WHILE CONNECTED TO THE PATIENT MONITORING DEVICE. THE USER REPORTED THAT THE PATIENT LATER EXPIRED IN THE INTENSIVE CARE UNIT.

    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 Death