BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 7064943 · Received November 28, 2017

    Report

    Report Number
    2520313-2017-00073
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    November 3, 2017
    Report Date
    November 28, 2017
    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
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT DC POWER CABLE WAS SHIPPED TO THE CUSTOMER WHO PERFORMED THE REPLACEMENT. BAYER PRODUCT ANALYSIS RECEIVED AND EXAMINED THE SUBJECT DC POWER CABLE. VISUAL EXAMINATION DETERMINED THAT THE SHIELDING BRAID WAS OUT OF POSITION AND THE WIRES SHOWED EVIDENCE OF BEING PULLED FROM THEIR TERMINAL CRIMPS. FURTHER EXAMINATION DETERMINED THAT THE BLACK WIRE WAS DISENGAGED FROM ITS CRIMP. PRODUCT ANALYSIS 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 SHUT DOWN. CONSEQUENTLY, THE POWER SUPPLY CONTINUES TO ENERGIZE THE CABLE WHICH CAN LEAD TO LOCALIZED HEATING AND MELTING OF THE POWER CABLE. ON (B)(4) 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. THE CUSTOMER RECEIVED NOTIFICATION OF THE RECALL AS EVIDENCED BY AN URGENT MEDICAL DEVICE COMPONENT RECALL FORM SIGNED ON (B)(4) 2013 AT WHICH TIME THEY DECLINED HAVING ANY AFFECTED CABLES ON SITE. 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 POWER SUPPLY WAS NOT CHARGING THE MONITOR BATTERIES. WHILE EVALUATING THE SYSTEM, THE SITE'S BIOMEDICAL ENGINEER NOTICED THE DC POWER CABLE BECAME VERY HOT TO TOUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841673 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MWI BAYER MEDICAL CARE, INC. 59352451

    Patients

    Seq Age Sex Outcome Treatment
    1