BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO

    MDR report key: 243401 · Received October 4, 1999

    Report

    Report Number
    2952494-1999-00017
    Event Type
    Injury
    Date Received
    October 4, 1999
    Report Date
    January 28, 1999
    Manufacturer
    FEM RX
    Product Code
    HIG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GYN PROCEDURE THE DEVICE WAS DISPLAYING INCORRECT FLUID MEASUREMENTS. AS A RESULT, THE PT EXPERIENCED A 7 LITER FLUID DEFICIT WHICH REQUIRED MEDICAL INTERVENTION. PT OUTCOME WAS POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO FLUID MANAGEMENT SYSTEM HIG FEM RX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN