BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDP NETVIEWER

    MDR report key: 5261154 · Received December 1, 2015

    Report

    Report Number
    3020646-2015-00001
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Date of Event
    June 23, 2015
    Report Date
    November 20, 2015
    Manufacturer
    VIDCO, INC.
    Product Code
    MSX
    PMA / PMN Number
    K972880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OCCURRED DURING AN INSTALLATION PERIOD FOR THREE NEWLY PURCHASED UNITS. THE INITIAL UNIT WAS REMOVED FROM INSTALLATION AND THE OTHER TWO WERE WITHHELD FROM INSTALLATION UNTIL ISSUE WAS RESOLVED. WE WORKED WITH THE CUSTOMER TO DETERMINE THE CAUSE. CUSTOMER PROVIDED NETWORK DATA RECORDING TO ASSIST IN PROBLEM REPRODUCTION TO HELP IN DETERMINING THE CAUSE OF THE PROBLEM. CUSTOMER SET DATE OF (B)(6) 2015 TO GO TO THEIR FACILITY TO INVESTIGATE. DURING THIS VISIT WE VERIFIED FREEZE MALFUNCTION AND DETERMINED THE STATE OF THE UNIT DURING THE FREEZE PERIOD. WE RETURNED TO FACTORY WITH CUSTOMER UNITS. ALL CUSTOMERS WITH THIS DEVICE REVISION WERE CONTACTED TO SEE IF ANYONE ELSE WAS EXPERIENCING THIS BEHAVIOR. NO OTHER CUSTOMER EXPERIENCED THIS ISSUE TO DATE. THROUGH IN-DEPTH TESTING AND COMMUNICATION WITH MANUFACTURER OF OUR NETWORK CONTROLLER DEVICE, AS WELL AS WEB SEARCHES, WE DETERMINED THE ROOT CAUSE OF THE MALFUNCTION, A DEFECT IN THE DEVICE'S NETWORK CONTROLLER CHIP. IT TOOK 6 WEEKS TO DEVELOP AND VALIDATE A SOLUTION THAT COULD BE USED FOR A CORRECTION FOR NEWLY MANUFACTURED DEVICES. THE SOLUTION WAS VALIDATED AND THE CUSTOMER'S 3 UNITS WERE RETURNED ON 9/9/2015. VIDCO HAS NEVER HAD A DEVICE INVOLVED IN AND RESPONSIBLE FOR AN ADVERSE EVENT. WE WERE AND STILL ARE UNCLEAR WHETHER REPORTING THIS MALFUNCTION WAS NECESSARY, BUT DECIDED TO ACT ON THE SIDE OF CAUTION EVEN THOUGH WE WERE SEVERAL MONTHS PAST THE INITIAL DISCOVERY OF THE MALFUNCTION.

    Description of Event or Problem · 1

    CUSTOMER AT (B)(6) HOSPITAL CALLED TO REPORT A DEVICE THEY WERE TRYING TO INSTALL WAS PERIODICALLY FREEZING UP AND COULD ONLY BE MADE OPERATIONAL AGAIN THROUGH CYCLING POWER TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790308 MDP NETVIEWER REMOTE PATIENT MONITORING SYSTEM MSX VIDCO, INC. MDP2040-0100

    Patients

    Seq Age Sex Outcome Treatment
    1