BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISION FLOW

    MDR report key: 1603395 · Received January 26, 2010

    Report

    Report Number
    1125759-2010-00001
    Event Type
    Other
    Date Received
    January 26, 2010
    Date of Event
    December 8, 2009
    Report Date
    January 25, 2010
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VAPOTHERM RECEIVED A MEDWATCH REPORT FROM THE FDA, NUMBER (B)(4), ON (B)(6) 2010. THE REPORT WAS FILED BY (B)(6). THE HOSPITAL REPORTED THAT HALF OF THE PRECISION FLOW RESPIRATORY HUMIDIFIER TEMP DISPLAY LED WENT OUT. THE EVENT WAS REPORTED TO VAPOTHERM ON (B)(6) 2009 AND WAS INCLUDED IN THE COMPLAINT SYSTEM AS C09-573. THE EVENT DID NOT MEET THE CRITERIA FOR MDR REPORTING. VAPOTHERM CONTACTED THE HOSPITAL BY TELEPHONE TO ADDRESS THE ISSUE. WHEN THE USER POWERED UP THE UNIT THEY WERE UNABLE TO DUPLICATE THE EVENT. THE UNIT WAS NOT RETURNED TO VAPOTHERM FOR SERVICE AND CONTINUES TO PERFORM CORRECTLY. VAPOTHERM CONSIDERS THE ISSUE CLOSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1