BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDP NETVIEWER

    MDR report key: 5261144 · Received December 1, 2015

    Report

    Report Number
    3020646-2015-00002
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Date of Event
    July 17, 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
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT'S DEVICE MALFUNCTION OCCURRED ON NEWLY INSTALLED UNIT IN ER USED FOR ADDITIONAL SURVEILLANCE MONITORING IN ROOM WITH CIC CENTRAL. WE HAD JUST BECOME AWARE OF THE FREEZE MALFUNCTION AND WERE IN THE PROCESS OF INVESTIGATION AND ENGINEERING A CORRECTION. WE SENT A LOANER UNIT TO CUSTOMER WITH INTERIM MITIGATION SOFTWARE AND VERIFIED WITH CUSTOMER FUNCTIONALITY. THERE WERE 16 ADDITIONAL UNITS INSTALLED IN NEW UNIT THAT WAS NOT LIVE YET AND THEY NEEDED THEM CORRECTED BEFORE THE GO LIVE DATE. WE WENT TO CUSTOMER'S FACILITY AND CORRECTED ALL 16 DEVICES ON (B)(6) 2015. FOLLOW-UP WITH CUSTOMER HAS VERIFIED NO FURTHER MALFUNCTION. 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 FIELD CORRECTION SOLUTION IS CURRENTLY IN VALIDATION. 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 HAD INSTALLED 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
    790269 MDP NETVIEWER REMOTE PATIENT MONITORING SYSTEM MSX VIDCO, INC. MDP2040-0100

    Patients

    Seq Age Sex Outcome Treatment
    1