BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRAL MONITORING SYSTEM

    MDR report key: 6013229 · Received October 9, 2016

    Report

    Report Number
    2032233-2016-00514
    Event Type
    Malfunction
    Date Received
    October 9, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 8, 2016
    Manufacturer
    NKUS LAB
    Product Code
    DRG
    PMA / PMN Number
    K102106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTS THAT THE PREFENSE DEVICE BOOTS UP AND TURNS OFF RIGHT AWAY. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE PREFENSE DEVICE BOOTS UP AND TURNS OFF RIGHT AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664664 CENTRAL MONITORING SYSTEM CENTRAL MONITORING STATION DRG NKUS LAB EDNS-9001

    Patients

    Seq Age Sex Outcome Treatment
    1