BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MWI

    MDR report key: 10104247 · Received June 1, 2020

    Report

    Report Number
    1051786-2020-00029
    Event Type
    Injury
    Date Received
    June 1, 2020
    Report Date
    May 21, 2020
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    UDI-DI
    00884838039131
    PMA / PMN Number
    K152330
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE CUSTOMER REQUESTED PHILIPS' SUPPORT IN EVALUATING THE DEVICE. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE AND EVALUATED THE DEVICE IN QUESTION. NO PROBLEMS WITH THE DEVICE WERE OBSERVED. THE DEVICE WAS TESTED AND VERIFIED TO PERFORM WITHIN MANUFACTURER SPECIFICATIONS.A GOOD FAITH EFFORT WAS MADE TO OBTAIN ADDITIONAL INFORMATION ASSOCIATED WITH THIS COMPLAINT, BUT NO ADDITIONAL INFORMATION HAD BEEN RECEIVED. FSE EVALUATION OF THE DEVICE WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. AS A RESULT, WE ARE UNABLE TO CONCLUDE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ER DOCTOR USED THE DEVICE DURING A CODE AND CLAIMS THE DEVICE DIDN'T WORK. AT THIS TIME, THERE IS NO INFORMATION AVAILABLE AS TO THE PATIENT OUTCOME OR ADDITIONAL DETAILS ABOUT THE DEVICE'S REPORTED FAILURE TO FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568987 MWI PHYSIOLOGICAL PATIENT MONITOR MWI INVIVO CORPORATION 866185 00884838039131

    Patients

    Seq Age Sex Outcome Treatment
    1