BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 2993103 · Received March 1, 2013

    Report

    Report Number
    2520313-2013-00011
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    September 7, 2012
    Report Date
    October 31, 2012
    Manufacturer
    MEDRAD
    Product Code
    MWI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER SERVICE CONFIRMED THAT THE POWER SUPPLY CABLE WAS MELTED AND THAT THE VERIS UNIT WOULD NOT CHARGE, BAYER R AND I PRODUCT ANALYSIS RECEIVED AND EVALUATED THE VERIS POWER SUPPLY MODULE AND THE VERIS POWER SUPPLY CABLE FROM THE SITE. VISUAL EXAMINATION CONFIRMED THE CONDITION OF THE RETURNED DC POWER CABLE INDICATING THAT THERE WAS AN INTERNAL TEMPERATURE SUFFICIENT TO MELT THE JACKET OF THE CABLE. THE OVERHEATING IN THE POWER CABLE WAS CONCENTRATED AT THE AREA WHERE THE COILS WERE GATHERED. THE CAUSE OF THE REPORTED PROBLEM IS A RUNAWAY CURRENT CONDITION THAT IS INITIATED BY A SHORT CIRCUIT WITHIN THE DC POWER CABLE. THE POWER SUPPLY MALFUNCTIONED DUE TO A BLOWN LINES FUSES AND CIRCUIT BOARD DAMAGE.

    Description of Event or Problem · 1

    A BAYER R AND I REPRESENTATIVE REPORTED THE FOLLOWING: THE VERIS UNIT WOULD NOT CHARGE. THE CABLE GOING FROM THE POWER MODULE TO THE VERIS WAS MELTED. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88716 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MWI MEDRAD 3011994

    Patients

    Seq Age Sex Outcome Treatment
    1