BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 3111840 · Received May 7, 2013

    Report

    Report Number
    2520313-2013-00020
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDRAD
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER R AND I PRODUCT ANALYSIS REVIEWED THE INFO IN THE COMPLAINT RECORD ALONG WITH PHOTOGRAPHS OF THE MELTED POWER SUPPLY CABLE 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 APRIL 15, 2013 BAYER HEALTHCARE DISTRIBUTED A FIELD SAFETY NOTICE RECALLING ALL 25-FOOT DC POWER CABLES SHIPPED WITH MEDRAD VERIS MR VITAL SIGNS MONITORS. 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 VERIS POWER SUPPLY CABLE WAS COILED AND MELTED TOGETHER. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200030 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MWI MEDRAD 3011992

    Patients

    Seq Age Sex Outcome Treatment
    1