BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR

    MDR report key: 1480776 · Received July 14, 2009

    Report

    Report Number
    2150060-2009-00112
    Event Type
    Malfunction
    Date Received
    July 14, 2009
    Date of Event
    June 18, 2009
    Report Date
    June 18, 2009
    Manufacturer
    MINNTECH CORPORATION
    Product Code
    NVE
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ASP CLINICAL EDUCATION CONSULTANT (CEC) CALLED TO REPORT A CUSTOMER ALLEGING THAT THE DISINFECTANT TIME ON THEIR AER UNIT IS SET AT ONE MINUTE. THE CEC INFORMED THE CUSTOMER THAT THE TIME NEEDED WITH THE USE OF CIDEX OPA IS 5 MINUTES. THE ACCOUNT WAS RE-INSERVICED FOR THE CORRECT TIME. THE CUSTOMER DID NOT HAVE INFORMATION REGARDING HOW LONG HAS THE SETTING BEEN AT ONE MINUTE, THE NUMBER OF SCOPES PROCESSED AND POTENTIAL PATIENT INJURIES. THE CUSTOMER HAS NOT RESPONDED TO ASP'S ATTEMPTS IN RETRIEVING MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR AER EQUIPMENT NVE MINNTECH CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CIDEX OPA, CATALOG #: 20390, LOT UNK