BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 3043055 · Received March 7, 2013

    Report

    Report Number
    2520313-2013-00015
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    August 7, 2012
    Report Date
    August 7, 2012
    Manufacturer
    MEDRAD, INC.
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) SERVICE CONFIRMED WITH THE CUSTOMER THAT THE POWER SUPPLY CORD WAS EXHIBITING AN ELEVATED TEMPERATURE AND THE VERIS MONITOR WAS SHUTTING OFF AND WOULD NOT CHARGE WITH THE EXISTING CHARGER. A NEW CHARGER AND POWER CORD WERE SENT TO THE CUSTOMER, WHICH REMEDIED THE REPORTED ISSUE. 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.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: THE VERIS POWER SUPPLY CORD IS GETTING HOT, THE VERIS MONITOR SHUT OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98471 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MWI MEDRAD, INC. 3011996W

    Patients

    Seq Age Sex Outcome Treatment
    1