BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS BPS

    MDR report key: 2545702 · Received April 20, 2012

    Report

    Report Number
    2545702
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Date of Event
    March 14, 2012
    Report Date
    April 16, 2012
    Manufacturer
    GENESIS BPS
    Product Code
    KSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS RECEIVING A PHLEBOTOMY PROCEDURE WITH THE BLOOD COLLECTION DEVICE ON THE SCALE WHEN THE SCALE TURNED OFF IN THE MIDDLE OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS BPS GENESIS BLOOD COLLECTION MONITOR KSQ GENESIS BPS CM350 *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR CHEMOTHERAPY