BEUDAMED
    FDA Adverse Event Summary report: N

    PRECISION FLOW

    MDR report key: 2508697 · Received March 16, 2012

    Report

    Report Number
    1125759-2012-00001
    Date Received
    March 16, 2012
    Date of Event
    December 21, 2011
    Report Date
    March 15, 2012
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORT: "WATER BAG WAS CHANGED AND THE UNIT STOPPED WORKING. TROUBLESHOT EQUIPMENT AND INSTRUCTION MANUAL INDICATED INTERNAL COMPONENT FAILURE. PT WAS PLACED ON DIFFERENT UNIT. NO HARM CAME TO THE PATIENT. BIOMED TAGGED, REMOVED, AND WILL TEST THE DEVICE." MANUFACTURER REPORT: VAPOTHERM HAS NOT HAD ANY CONTACT FROM THE HOSPITAL REQUESTING TO FILE A CUSTOMER COMPLAINT OR REQUEST SERVICE. VAPOTHERM CONTRACTED THE HOSPITAL AND WAS TOLD THE UNIT WAS TESTED BY THE BIOMED. HE COULD NOT FIND ANYTHING WRONG WITH IT AND PLACED IT BACK IN SERVICE. THERE HAS BEEN NO FURTHER ISSUES WITH THIS UNIT SINCE THEN. ISSUE APPEARS TO HAVE BEEN CAUSED BY USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION FLOW HUMIDIFIER BTT VAPOTHERM, INC. PRECISION FLOW

    Patients

    Seq Age Sex Outcome Treatment
    1