BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 3217127 · Received July 3, 2013

    Report

    Report Number
    2520313-2013-00036
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MEDRAD
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER R & I SERVICE REPLACED THE CHARGER AND NOTED THAT IT HAD SHORTED DUE TO MELTED WIRES IN THE POWER CABLE. THE SUPPLY CABLE WAS DISCARDED BY BIOMEDICAL PERSONNEL AT THE SITE AND THEREFORE, UNAVAILABLE FOR OUR INVESTIGATION. BAYER S & I PRODUCT ANALYSIS REVIEWED THE INFORMATION IN THE COMPLAINT RECORD AND DETERMINED THIS TO BE A RUNAWAY CURRENT CONDITION THAT IS INITIATED BY A SHORT CIRCUIT WITHIN THE DC POWER CABLE. A SUBSEQUENT INVESTIGATION OF SIMILAR COMPLAINTS 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)(6) 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. THESE POWER CABLES ARE BEING 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 SITE REPORTED THE FOLLOWING: MONITOR WILL NOT STAY ON. THE VERIS MONITOR SYSTEM WAS CHECKED BY BIOMEDICAL ENGINEER AT THE SITE AND DETERMINED THAT THE CHARGER WAS CAUSING THE REPORTED SYMPTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304214 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MHX MEDRAD 3011996W

    Patients

    Seq Age Sex Outcome Treatment
    1