BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAPOTHERM 2000I

    MDR report key: 1525533 · Received October 22, 2009

    Report

    Report Number
    1125759-2009-00011
    Event Type
    Other
    Date Received
    October 22, 2009
    Date of Event
    May 4, 2009
    Report Date
    October 14, 2009
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT REC'D BY MFR.

    Description of Event or Problem · 1

    VAPOTHERM HAS REC'D A MEDWATCH REPORT NUMBER (B)(4). VAPOTHERM HAS REVIEWED ITS COMPLAINT SYSTEM RECORDS AND DETERMINED THAT THE HOSPITAL DID NOT CONTACT US CONCERNING THE ISSUE. HOSPITAL EVENT DESCRIPTION: PREMATURE INFANT WITH POSITIVE RALSTONIA CULTURE FROM PT ON VAPOTHERM HUMIDIFIER AND VENTRICULAR ASSESS DEVICE (VAD). IV ANTIBIOTICS, CEFATAXIME AND VANCOMYCIN, INITIATED ON SAME DAY. SUBSEQUENT VAD CULTURES, OBTAINED 3 DAYS LATER AND 7 DAYS LATER WERE NEGATIVE. INITIAL SENSITIVITY RESULTS FROM THE DATE OF THE EVENT REVEALED ORGANISM NOT SENSITIVE TO PRESCRIBED ANTIBIOTICS ORDERED. THUS, TOGETHER WITH SUBSEQUENT NEGATIVE VAD CULTURES X 2 LED REVIEWERS TO CONCLUDE THAT CULTURE FOR RASTONIA WAS A CONTAMINATE. MFR RESPONSE: THE HOSP PROVIDED DATA THAT THE CULTURES FROM SIX UNITS WERE NEGATIVE AND THE UNITS WERE RETURNED TO SERVICE. VAPOTHERM CONCLUDES THERE WAS NO PRODUCT ISSUE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOTHERM 2000I 2000I BTT VAPOTHERM, INC. 2000I

    Patients

    Seq Age Sex Outcome Treatment
    1