BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISION FLOW

    MDR report key: 1413675 · Received July 2, 2009

    Report

    Report Number
    1125759-2009-00007
    Event Type
    Other
    Date Received
    July 2, 2009
    Date of Event
    April 15, 2009
    Report Date
    June 23, 2009
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VAPOTHERM RECEIVED A MEDWATCH REPORT FROM THE FDA ON JUNE 19, 2009. THE MEDWATCH REPORT WAS FILED BY (B)(6) HOSPITAL FOR (B)(6) THE PRODUCT INVOLVED WAS A PRECISION FLOW RESPIRATORY HUMIDIFIER UNIT THAT DELIVERS HUMIDIFIED HEATED GAS TO A PT. THE PRECISION FLOW IS NOT A LIFE SUPPORTING DEVICE. AN INVESTIGATION WAS PERFORMED ON THE PRECISION FLOW UNIT THAT WAS INVOLVED IN THE INCIDENT. WE FOUND THAT A CIRCUIT BOARD COMPONENT HAD OVERHEATED AND CAUSED THE INTERNAL MAGNETIC PUMP DRIVE STATOR TO STOP WORKING. THE COMPONENT OVERHEATING WAS CAUSED BY A GAP BETWEEN THE PUMP STATOR CUP AND ITS MATING UNIT HOUSING SURFACE. VAPOTHERM IS UNAWARE OF ANY PT HARM AND THE HOSPITAL'S REPORT DOES NOT REPORT ANY PT'S CONCERN.

    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