BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RNS-9703-19

    MDR report key: 4768673 · Received May 11, 2015

    Report

    Report Number
    8030229-2015-00085
    Event Type
    Malfunction
    Date Received
    May 11, 2015
    Date of Event
    April 6, 2015
    Report Date
    April 6, 2015
    Manufacturer
    NIHON KOHDEN CORP.
    Product Code
    MHX
    PMA / PMN Number
    K023475
    Removal / Correction Number
    2080783-04-15/15-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATES THAT THEY HAVE SEVERAL UNITS THAT DID NOT HAVE AUDIBLE SOUND AND THE UNITS WERE RESTARTED AND WERE NOW FUNCTIONING. WE HAVE NOT RECEIVED THE UNIT COUNT OR SERIAL NUMBER INFO FROM THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AUDIBLE ALARMS SPONTANEOUSLY STOPS ALARMING FOR THE REMOTE NETWORK STATION (RNS OR REMOTE MONITORING SYSTEM). ALSO, WHEN THEY CHECKED THAT SOUND CONTROL, THE VOLUME SETTING IS ALL THE WAY DOWN AND WILL NOT ALLOW THE USER TO RAISE IT. THEY STATED THAT THE ONLY FIX HE HAS FOUND IS TO UNPLUG THE RNS POWER CORD AND ESSENTIALLY HARD RESTARTING THE RNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308369 RNS-9703-19 REMOTE NETWORK STATION MHX NIHON KOHDEN CORP. RNS-9703-019

    Patients

    Seq Age Sex Outcome Treatment
    1 NI