BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MRVITAL SIGNS MONITOR

    MDR report key: 3185658 · Received June 19, 2013

    Report

    Report Number
    2520313-2013-00035
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MEDRAD
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER R & I SERVICE REPLACED THE POWER SUPPLY (B)(4) 2013. BAYER R & I PRODUCT ANALYSIS RECEIVED AND EXAMINED THE TWO RETURNED DC POWER CABLES (B)(4) 2013. THE EXAM OF THE LEMO CONNECTOR AND THE ADJOINING WIRES DETERMINED THAT ONE OF THE WIRES HAD CROSSED OVER AND SHORTED WITH ANOTHER CONDUCTOR TO THE POINT WHERE THE INSULATION OF THE TWO CONDUCTORS BECAME WARM. 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. 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

    A BAYER R & I FIELD SERVICE REP REPORTED THE FOLLOWING: THE CUSTOMER REPORTS VERIS IS NOT CHARGING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279521 MEDRAD VERIS MRVITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL DQA MEDRAD 3011994W

    Patients

    Seq Age Sex Outcome Treatment
    1