BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXHALENT

    MDR report key: 2068086 · Received March 30, 2011

    Report

    Report Number
    2954339-2011-00011
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 30, 2011
    Manufacturer
    STARION INSTRUMENTS
    Product Code
    HQR
    PMA / PMN Number
    K050308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXHALENT WAS RETURNED, DECONTAMINATED AND INVESTIGATED. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED EXHALENT AND FOUND THAT THE TURBINATE HEATER WAS SEPARATED AND NOT RETURNED WITH THE DEVICE WHICH CONFIRMED THE COMPLAINT. THE PLASTIC INSULATOR WHICH HOLDS THE HEATER WAS PARTIALLY MELTED AT THE DISTAL EDGE. IF THE HEATING ELEMENT (TIP) GETS TOO HOT AND IS MANIPULATED, IT MAY SEPARATE FROM THE INSULATOR WHICH HOLDS IT. DUE TO THE CONDITION OF THE RETURNED DEVICE, THE OVERALL PERFORMANCE COULD NOT BE TESTED FOR ABNORMAL ACTIVATION. INDIVIDUAL COMPONENTS WERE EVALUATED FOR PRODUCING HIGH TIP TEMPERATURES. THE RETURNED DEVICE MEETS THE FUNCTIONAL REQUIREMENTS AND IS WORKING NORMALLY. THE PROBABLE CAUSE WAS THAT THE HEATER WAS NOT PROPERLY PLACED WITHIN THE TISSUE SITE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE DEVICE CAME OFF AND WAS RETRIEVED. NO PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXHALENT EXHALENT HQR STARION INSTRUMENTS 143-021D 006007

    Patients

    Seq Age Sex Outcome Treatment
    1