BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISION FLOW

    MDR report key: 2574367 · Received March 23, 2012

    Report

    Report Number
    1125759-2012-00002
    Event Type
    Other
    Date Received
    March 23, 2012
    Date of Event
    February 17, 2012
    Report Date
    March 15, 2012
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP REPORT: "FLUID DID NOT FLOW, CAUSING UNIT TO BLOW DRY AIR TO PT. DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO." MFR: THE HOSP HAD NOT CONTACTED VAPOTHERM TO FILE A CUSTOMER COMPLAINT OR REQUEST SERVICE FOR THEIR PRECISION FLOW (PF) UNIT PRIOR TO VAPOTHERM RECEIVING THE MEDWATCH FORM. THE PF IS USED TO CONDITION BREATHING GASES WITH WARMTH AND HUMIDITY FOR THE COMFORT OF THE PT. THE PF IS DESIGNED TO CONTINUE TO DELIVER BREATHING GAS WHEN THERE IS A PERFORMANCE ISSUE ALTHOUGH THE GAS WILL NOT BE CONDITIONED. THE UNIT IS DESIGNED TO ISSUE AN AUDIBLE ALARM WHEN THE UNIT EXPERIENCES DIFFICULTY WITH THE WATER SYSTEM. THE PF OPERATING INSTRUCTION MANUAL ADVISES THE USER; "IF THE DEVICE IS DAMAGED OR NOT WORKING PROPERLY. DO NOT USE. CONTACT VAPOTHERM OR YOUR AUTHORIZED VAPOTHERM REPRESENTATIVE."

    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