BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYVASO INHALATION SYSTEM

    MDR report key: 3202279 · Received July 1, 2013

    Report

    Report Number
    MW5030705
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 25, 2013
    Manufacturer
    UT GMBH
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT WITH CHRONIC PULMONARY HEART DISEASE, WHO INITIATED INHALED TYVASO (TREPROSTINIL) ON (B)(6) 2013 AT 18-54 MICROGRAMS (THREE TO NINE BREATHS) FOUR TIME PER DAY, REPORTED THAT LAST WEEK WHEN SHE PLUGGED HER OPTINEB INTO THE BATTERY THE UNIT SMOKED LIKE IT WOULD CATCH FIRE. AT THE TIME OF THE REPORT, SHE WAS USING HER OTHER OPTINEB, WHICH WORKED, BUT IT DID NOT SEEM LIKE IT WAS GIVING OUT THE SAME AMOUNT OF MEDICATION, BUT NOT AS MUCH; SHE COULDN'T TASTE THE MEDICATION, LIKE SHE DID PREVIOUSLY. SHE WAS ADVISED THAT A BATTERY REPLACEMENT AND TWO OPTINEB'S WOULD BE SHIPPED TO HER OVERNIGHT. SHE CONFIRMED SHE WOULD SEND HER OPTINEB'S BACK, AND THAT THE OPTINEB SHE WAS PRESENTLY USING DID BUBBLE DOWN. CONSUMER REPORTER DETAILS WITHHELD, USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297719 TYVASO INHALATION SYSTEM NEBULIZER CAF UT GMBH ON-100/7

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other TYVASO