BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GETINGE

    MDR report key: 4458960 · Received November 7, 2014

    Report

    Report Number
    9616031-2014-00005
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIFIC MODEL NUMBER OF THE WASHER DISINFECTOR 46-5T IS NOT AVAILABLE IN THE US. HOWEVER, THE ACCESSORY RACK THAT MAY BE THE POTENTIAL SOURCE OF THE BLUE DEBRIS IS UTILIZED FOR ALL 46 SERIES WASHER DISINFECTORS THAT ARE AVAILABLE IN THE US. F/U REPORT TO BE SUBMITTED.

    Description of Event or Problem · 1

    A SMALL PIECE OF BLUE DEBRIS/SUBSTANCE WAS OBSERVED IN A PHACOEMULSIFICATION HAND PIECE AFTER CLEANING IN A 46 SERIES WASHER DISINFECTOR USING A RACK ACCESSORY (MIS UO-MODULE_MIS MODULAR - L SHAPE WITH FILTER). THIS WAS OBSERVED 5-6 TIMES AT THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720914 GETINGE WASHER DISINFECTOR MEC GETINGE DISINFECTION AB 46-5

    Patients

    Seq Age Sex Outcome Treatment
    1