BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS

    MDR report key: 4192518 · Received September 26, 2014

    Report

    Report Number
    4192518
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 12, 2014
    Report Date
    September 26, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE MRI COMPATIBLE SPO2 CABLE AND SENSOR ASSEMBLY IS DELICATE AND BREAKS OFTEN. IT IS NOT DESIGNED FOR ITS USE ENVIRONMENT. THE REPAIR COST EACH OCCURRENCE IS AROUND $1400. BREAKAGE OCCURS ABOUT EVERY 4 MONTHS.MANUFACTURER RESPONSE FOR MRI COMPATIBLE PHYSIOLOGICAL MONITOR SPO2, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================REPLACEMENT PARTS ARE AVAILABLE FOR PURCHASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600061 MEDRAD VERIS MONITOR, MRI COMPATIBLE PHYSIOLOGICAL, SPO2 MHX BAYER MEDICAL CARE, INC. VERIS 8600 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES