BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAPOTHERM

    MDR report key: 692448 · Received March 23, 2006

    Report

    Report Number
    1125759-2006-00008
    Event Type
    Other
    Date Received
    March 23, 2006
    Date of Event
    December 13, 2005
    Report Date
    March 22, 2006
    Manufacturer
    VAPOTHERM INC.
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VAPOTHERM RECEIVED A LETTER FROM THE FDA STATING THAT WOMEN'S AND INFANTS HOSPITAL HAD FILED A CONFIDENTIAL REPORT STATING THAT "ABOUT 5 UNITS HAD BEEN CULTURED AND SOME WERE POSITIVE" FOR RALSTONIA. NO INJURIES OR DEATHS WERE REPORTED, AND ALTHOUGH MACHINES CULTURED POSITIVE, THE GAS FLOW/PATIENT SIDE DID NOT. AFTER CHANGING DISINFECTION RECOMMENDATIONS IN OCTOBER 2005, THE HOSPITAL HAD NO NEW CULTURES OF RALSTONIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other