BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 3074879 · Received April 19, 2013

    Report

    Report Number
    2520313-2013-00019
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDRAD
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER R AND I SERVICE REPLACED THE POWER CHARGER AND POWER SUPPLY CABLE. BAYER R AND I PRODUCT ANALYSIS RECEIVED AND EXAMINED THE DC POWER CABLE AND POWER SUPPLY. THE EXAMINATION 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 CHARRED. 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)(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. 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: THE POWER SUPPLY WAS NOT CHARGING THE MONITOR BATTERIES. WHILE ON SITE, A BAYER R AND I SERVICE REP NOTICED THE DC POWER CABLE BECAME VERY HOT TO TOUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168969 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MHX MEDRAD 3011996

    Patients

    Seq Age Sex Outcome Treatment
    1