BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    MDR report key: 5508964 · Received March 17, 2016

    Report

    Report Number
    2520313-2016-00016
    Event Type
    Malfunction
    Date Received
    March 17, 2016
    Date of Event
    February 22, 2016
    Report Date
    February 22, 2016
    Manufacturer
    BAYER MEDICAL CARE
    Product Code
    MWI
    PMA / PMN Number
    K042569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER SERVICE RESPONDED TO THE SITE AND REPLACED THE SYSTEM BATTERIES, CHARGER CARD, AND PCB MAIN BOARD. THIS RETURNED THE SYSTEM TO NORMAL OPERATION. THE MAIN PCB BOARD WAS REQUESTED TO BE RETURNED TO BAYER PRODUCT ANALYSIS FOR EVALUATION. THE RETURNING PART WAS LOST IN TRANSIT VIA DHL. DHL IS UNABLE TO PROVIDE THE LOCATION OF THIS ITEM; THEREFORE WE ARE UNABLE TO PROVIDE ANY FURTHER INFORMATION.

    Additional Manufacturer Narrative · 1

    BAYER SERVICE RESPONDED TO THE SITE AND REPLACED THE SYSTEM BATTERIES, CHARGER CARD, AND PCB MAIN BOARD. THIS RETURNED THE SYSTEM TO NORMAL OPERATION. QUALITY ASSURANCE PRODUCT ANALYSIS IS WAITING ON THE RETURN OF THE AFFECTED PARTS FOR EVALUATION. ONCE OUR INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A BAYER REPRESENTATIVE REPORTED THE FOLLOWING: THE CUSTOMER REPORTED THAT THE VERIS MONITOR POWERED OFF DURING USE. THERE WAS NO ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165477 MEDRAD VERIS MR VITAL SIGNS MONITOR MONITOR, PHYSIOLOGICAL PATIENT MWI BAYER MEDICAL CARE 3011994W

    Patients

    Seq Age Sex Outcome Treatment
    1