BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER

    MDR report key: 2181508 · Received July 25, 2011

    Report

    Report Number
    2181508
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    November 14, 2007
    Report Date
    November 19, 2007
    Manufacturer
    STRYKER
    Product Code
    FYD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    OPERATING ROOM NURSE REPORTS: NEPTUNE ROVER HAD AN ERROR WHICH READS "FLUID VOLUME ERROR, VOLUME DISABLED, READ LITERATURE". NURSE WAS UNABLE TO DETERMINE THE ACTUAL BLOOD LOSS FROM THE NEPTUNE READING. THIS IS A DEVICE WHICH MEASURES AND ESTIMATES THE LOSS OF BLOOD DURING SURGERY. THERE WAS NO INJURY TO PATIENT.======================MANUFACTURER RESPONSE FOR BLOOD MEASURING DEVICE USED DURING SURGERY TO ESTIMATE BLOOD LOSS, NEPTUNE ROVER (PER SITE REPORTER)======================MANUFACTURER WILL BE NOTIFIED VIA THIS MEDWATCH FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE ROVER BLOOD MEASURING DEVICE USED DURING SURGERY TO ESTIMATE BLOOD FYD STRYKER 700-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR