BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS INCUBATOR

    MDR report key: 1481853 · Received July 17, 2009

    Report

    Report Number
    1056600-2009-00150
    Event Type
    Malfunction
    Date Received
    July 17, 2009
    Date of Event
    June 25, 2009
    Report Date
    July 17, 2009
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    JTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DISCARDED THE CARDS THAT WERE IN THE INCUBATOR WHEN ISSUE WAS OBSERVED. INVESTIGATION CONDUCTED REGARDING THE RETURNED MTS INCUBATOR. THE INCUBATOR TEMPERATURE IS WITHIN SPECIFIED RANGE. THE CUSTOMER'S CONCERN WAS NOT CONFIRMED. THE CUSTOMER RECEIVED A REPLACEMENT INCUBATOR TO RESOLVE THE ISSUE. (B) (4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TEMPERATURE OF THE MTS INCUBATOR WAS OUT OF SPECIFICATION. NO ERRONEOUS RESULTS WERE REPORTED. A TEMPERATURE OUT OF SPECIFICATION, IF UNDETECTED DURING TESTING MAY LEAD TO ERRONEOUS TEST RESULTS AND MAY LEAD TO THE TRANSFUSION OF INCOMPATIBLE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS INCUBATOR MTS GEL CARD INCUBATOR JTQ MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1