BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS INCUBATOR

    MDR report key: 942952 · Received November 13, 2007

    Report

    Report Number
    1056600-2007-00313
    Event Type
    Malfunction
    Date Received
    November 13, 2007
    Date of Event
    October 19, 2007
    Report Date
    November 13, 2007
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    JTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    USER ERROR IDENTIFIED AS ROOT CAUSE. SALINE LEAKED INSIDE INCUBATOR. PRODUCT LABELING STATES "DO NOT POUR LIQUID OVER THE INSTRUMENT." (MTS INCUBATOR USER'S GUIDE 2004-06-30 P.9) ASSISTANCE PROVIDED TO THE CUSTOMER OVER THE PHONE HAS RESOLVED THE ISSUE. INSTRUMENT HAS BEEN REMOVED FROM SERVICE AND DISPOSED BY CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT THE INCUBATOR GENERATED SMOKE. THE CUSTOMER HAD A 3 GALLON CONTAINER OF SALINE ABOVE THE INCUBATOR. THE SALINE LEAKED INSIDE THE INCUBATOR AND MELTED THE CIRCUIT BOARD INSIDE CAUSING SMOKE TO GENERATE FROM THE INSIDE. NO FIRE OR SHOCK REPORTED AS A RESULT OF THIS INCIDENT. NO DEATH OR SERIOUS INJURY WAS REPORTED.

    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 YR