BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 3042970 · Received March 7, 2013

    Report

    Report Number
    2520313-2013-00016
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    MEDRAD
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDRAD SERVICE REPLACED THE POWER SUPPLY MODULE AND POWER SUPPLY CABLE. THE VERIS POWER SUPPLY MODULE WAS RETURNED TO PRODUCT ANALYSIS FOR EVALUATION. A VISUAL EXAMINATION DETERMINED THAT FUSES WERE BLOWN. 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 VERIS POWER SUPPLY CABLE IS GETTING VERY HOT AND IS NOT CHARGING THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98416 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MWI MEDRAD 3014268W

    Patients

    Seq Age Sex Outcome Treatment
    1