BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIVATORS

    MDR report key: 1970326 · Received January 25, 2011

    Report

    Report Number
    2150060-2011-00003
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Report Date
    January 10, 2011
    Manufacturer
    MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE PRODUCT PRODUCTION RUN ONE HANDLE AND BLOCK OF ONE ASSEMBLE WAS INVERTED. THE SUBSEQUENT QUALITY CONTROL CHECK WAS MISSED. THE SITUATION HAS BEEN DETERMINED TO BE AN ISOLATED INCIDENT. IT WAS DETERMINED ONLY ONE ASSEMBLY WAS EFFECTED. INTERNAL CORRECTIVE ACTION WAS INITIATED. RETRAINING OF PERSONNEL HAS OCCURRED AND THE MANUFACTURING PROCESS HAS BEEN EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE CONNECTION BLOCK AND HANDLE ORIENTATION WAS INCORRECT ON HOOK-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIVATORS HOOK-UP FEB MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH 2-8-711HAN 657828

    Patients

    Seq Age Sex Outcome Treatment
    1 Other