BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 83 PLUS 2

    MDR report key: 3820701 · Received April 11, 2014

    Report

    Report Number
    2523209-2014-00013
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 14, 2014
    Report Date
    April 10, 2014
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    KOG
    PMA / PMN Number
    K983017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE NO REPORTED INJURIES. THIS INCIDENT IS CURRENTLY UNDER INVESTIGATION, AS MORE INFORMATION BECOMES AVAILABLE WE WILL SEND A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A CULTURE OF MUCOGENICUM WAS FOUND DURING MONTHLY TESTING. THE CULTURE WAS IDENTIFIED AS A RESULT OF A WATER SAMPLE TEST CONDUCTED (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221617 SYSTEM 83 PLUS 2 ENDOSCOPE WASHER DISINFECTOR KOG CUSTOM ULTRASONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1