BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RNS-9703-19

    MDR report key: 4787295 · Received May 18, 2015

    Report

    Report Number
    8030229-2015-00098
    Event Type
    Malfunction
    Date Received
    May 18, 2015
    Date of Event
    April 22, 2015
    Report Date
    April 22, 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
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE NO PT INJURY OR ADVERSE EVENT. THE CUSTOMER CHECKED THEIR UNIT IN RESPONSE TO THE NOTIFICATION SENT TO THEM FROM US AND FOUND THIS ISSUE. AWAITING REQUESTED DEVICE FOR REPAIR AND FAILURE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE REMOTE NETWORK STATION (RNS OR REMOTE MONITORING SYSTEM) HAS NO AUDIBLE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321292 RNS-9703-19 REMOTE NETWORK STATION MHX NIHON KOHDEN CORP. RNS-9703-019

    Patients

    Seq Age Sex Outcome Treatment
    1 NI