BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 9364577 · Received November 22, 2019

    Report

    Report Number
    2520313-2019-00056
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    November 14, 2019
    Report Date
    December 20, 2019
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    MHX
    PMA / PMN Number
    K042569
    Removal / Correction Number
    Z-1586-2013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    A BAYER SERVICE REPRESENTATIVE VISITED THE SITE AND REPLACED THE POWER CABLE, POWER CORD SET, POWER SUPPLY AND O2 SENSOR AND THE SYSTEM WAS RETURNED TO NORMAL OPERATION. PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED COMPONENTS. VISUAL INSPECTION OF THE POWER CABLE CONFIRMED THAT THE CABLE HAD MELTED, AND SEVERAL AREAS SHOWED EXPOSED WIRING. THE LEMO CONNECTOR WAS REMOVED AND SEVERAL OF THE WIRES SHOWED THERMAL DEGRADATION OF THEIR INSULATION, LEADING TO EXPOSED CONDUCTORS. PRODUCT ANALYSIS DETERMINED THE CAUSE OF THE REPORTED ISSUE WAS DAMAGE TO THE LEMO CONNECTOR WIRING WHICH LED TO A SHORT CIRCUIT CONDITION AND, SUBSEQUENTLY, THE MELTING OF THE CABLES AND REPORTED ELECTRICAL SHOCK. ON APRIL 15, 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 RECORDS CONFIRMED THAT AN URGENT MEDICAL DEVICE COMPONENT RECALL FORM AND LETTER WAS SENT TO THE CUSTOMER ON THREE SEPARATE OCCASIONS, NONE OF WHICH WERE ACKNOWLEDGED AND RETURNED. THE SITE CONTINUED TO USE THE AFFECTED CABLE UNTIL THE TIME OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING: UPON UNPLUGGING THE VERIS MR VITAL SIGNS MONITOR, THE TECHNOLOGIST IMMEDIATELY FELT A SHOCK SENSATION TO HIS HAND. HE WAS EVALUATED IN THE EMERGENCY DEPARTMENT AT WHICH TIME HE WAS CONFIRMED TO HAVE SUSTAINED BURNS TO THREE OF HIS FINGERS. THERE IS NO OTHER INFORMATION AVAILABLE AS TO THE EMPLOYEE'S CURRENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155813 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MHX BAYER MEDICAL CARE INC. 59350459

    Patients

    Seq Age Sex Outcome Treatment
    1 Other