BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSM-6300

    MDR report key: 5005237 · Received August 12, 2015

    Report

    Report Number
    2080783-2015-00210
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    NIHON KOHDEN CORP.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WLAN RECENTLY INSTALLED TO SUPPORT THE BEDSIDE VITAL SIGN MONITOR (B)(6) IS CAUSING AN ISSUE WITH THEIR ASCOM SYSTEM. REFERENCE MFR #: 8030229-2015-00210.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529243 BSM-6300 VITAL SIGN MONITOR MHX NIHON KOHDEN CORP. BSM-6300

    Patients

    Seq Age Sex Outcome Treatment
    1 NI