BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 7309026 · Received March 2, 2018

    Report

    Report Number
    2520313-2018-00025
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 15, 2018
    Report Date
    March 1, 2018
    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
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER SERVICE REPLACED THE POWER CABLE AND THE SYSTEM WAS RETURNED TO NORMAL WORKING ORDER. THE SUBJECT POWER CABLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. A PREVIOUS INVESTIGATION CONCLUDED THAT WHEN CERTAIN COMBINATIONS OF CONDUCTORS SHORT TOGETHER AT THE CABLE END FARTHEST FROM THE POWER SUPPLY, THIS CAN CREATE A CONDUCTION PATHWAY THAT THE POWER SUPPLY DOES NOT RECOGNIZE AS A SHORT CIRCUIT AND SHUTS DOWN. CONSEQUENTLY, THE POWER SUPPLY CONTINUES TO ENERGIZE THE CABLE WHICH CAN LEAD TO LOCALIZED HEATING AND MELTING OF THE POWER CABLE. ON APRIL 25, 2013 BAYER HEALTHCARE 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. THOSE POWER CABLES WERE RECALLED DUE TO A LATENT DESIGN RELIABILITY ISSUE AND THE POTENTIAL FOR SHORTING WHICH COULD RESULT IN HEATING/MELTING OF THE CABLE JACKET. PRODUCT ANALYSIS REVIEWED THE SYSTEM SERIAL NUMBER AND DETERMINED THAT THE SYSTEM WAS SUBJECT TO THIS RECALL AND THE POWER CABLE SHOULD HAVE BEEN RETURNED. BAYER HEALTHCARE SENT THREE NOTIFICATIONS TO THE CUSTOMER EACH OF WHICH WENT UNANSWERED. THE SITE CONTINUED TO USE THE AFFECTED CABLE UNTIL THE TIME OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: THE VERIS POWER CABLE HAD OVERHEATED. NO INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154943 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MWI BAYER MEDICAL CARE, INC. 59352451

    Patients

    Seq Age Sex Outcome Treatment
    1