BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2032233-2017-00239

    MDR report key: 7651668 · Received June 29, 2018

    Report

    Report Number
    2032233-2017-00239
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    May 31, 2018
    Report Date
    June 29, 2018
    PMA / PMN Number
    K023475
    Removal / Correction Number
    2080783-04-15/15-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE RNS WAS RESETTING THE GROUP NAMES BACK TO THEIR DEFAULT VALUE. NIHON KOHDEN IS CURRENTLY WORKING WITH THEM TO RESOLVE THE ISSUE. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR PART 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RNS WAS RESETTING THE GROUP NAMES BACK TO THEIR DEFAULT VALUE.

    Patients

    Seq Age Sex Outcome Treatment
    1