BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 8749668 · Received July 1, 2019

    Report

    Report Number
    2520313-2019-00031
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    May 2, 2019
    Report Date
    July 1, 2019
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    MWI
    PMA / PMN Number
    K042569
    Removal / Correction Number
    Z-1586-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER SERVICE REPLACED THE AFFECTED POWER CABLE AND RESTORED THE SYSTEM TO NORMAL OPERATION. BAYER PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED POWER CABLE. THE EXTERIOR CABLE APPEARED TO BE IN NORMAL CONDITION. THE LEMO CONNECTOR WAS REMOVED TO EXAMINE THE WIRE LEADS. SEVERAL LEADS WERE FOUND EXPOSED AND OUTSIDE OF THE INSULATION RESULTING IN A SHORT CIRCUIT CONDITION AND SUBSEQUENT HEATING. THE CABLE WAS CONFIRMED TO BE A PREVIOUSLY RECALLED CABLE. BAYER BV PROVIDED AND CONFIRMED VIA A CUSTOMER TRACKER THAT THE RECALL NOTIFICATION WAS SHARED WITH THE CUSTOMER ON JULY 23, 2013. ADDITIONAL COMMUNICATION WITH THE CUSTOMER REVEALED THAT THE STAFF MEMBER WHO RECEIVED THE RECALL LETTER IN 2013 IS NO LONGER WORKING AT THE SITE, SO IT IS UNKNOWN AT THIS TIME AS TO WHY THE CUSTOMER CONTINUED TO USE THE RECALLED PRODUCT. ON APRIL 15, 2013 BAYER MEDICAL CARE DISTRIBUTED A FIELD SAFETY NOTICE RECALLING ALL 25-FOOT DC POWER CABLES SHIPPED WITH MEDRAD VERIS MR VITAL SIGNS MONITORS, OR THOSE PROVIDED BY BAYER SERVICE. THESE POWER CABLES WERE RECALLED DUE TO A LATENT DESIGN RELIABILITY ISSUE AND THE POTENTIAL FOR SHORTING WHICH CAN RESULT IN HEATING/MELTING OF THE CABLE JACKET.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CHARGER CABLE FOR THE VERIS MONITOR WAS WARM TO THE TOUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543188 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MWI BAYER MEDICAL CARE, INC. 59352451

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention