BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1365294 · Received March 6, 2009

    Report

    Report Number
    2150060-2009-00015
    Event Type
    Malfunction
    Date Received
    March 6, 2009
    Date of Event
    February 5, 2009
    Report Date
    February 5, 2009
    Manufacturer
    MINNTECH CORP.
    Product Code
    NVE
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT CURRENTLY CIDEX OPA IS USED WITH THE AER UNIT AND REQUESTED TO LEARN HOW TO SET THE UNIT TO INCLUDE A 5-MINUTE DISINFECT TIME. AT THIS POINT, IT HAS BEEN NOTED THERE HAS BEEN IMPROPER USE OF THE UNIT AND THE CIDEX SOLUTION TO ACHIEVE HLD FOR THE DEVICES. THE CUSTOMER STATED THAT THERE WERE NO INJURIES REPORTED FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER AER EQUIPMENT NVE MINNTECH CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA