BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION FLOW

    MDR report key: 3057512 · Received March 21, 2013

    Report

    Report Number
    1125759-2013-00001
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 21, 2013
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    CAX
    PMA / PMN Number
    K072845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PRECISION FLOW UNIT IN ITALY WAS REPORTED TO HAVE BEEN EXPERIENCING FLOW RATES THAT WERE HIGHER THAN THE DIALED IN SETTING. THE HIGH FLOWS COULD CONTINUE FOR UP TO 15 SECONDS BEFORE A GENERAL FAULT ALARM WOULD BE TRIGGERED. THERE WERE NO PT INJURIES AS A RESULT HOWEVER 15 SECONDS OF HIGHER THAN DESIRED FLOW RATES COULD POTENTIALLY CONTRIBUTE TO A PT INJURY IF IT WERE TO OCCUR AGAIN. THE BLOCKED TUBE ALARM IS DESIGNED TO PREVENT THE FLOW RATE FROM INCREASING MORE THAN 10% ABOVE THE DIALED IN FLOW RATE. HOWEVER, IN THIS CASE THE BLOCK TUBE ALARM FUNCTION HAD BEEN TURNED OFF DURING A PREVIOUS SERVICING OF THE DEVICE AT A SERVICE CENTER SELECTED BY THE DISTRIBUTOR. THIS FUNCTION SHOULD HAVE BEEN TURNED BACK ON PRIOR TO SENDING THE UNIT BACK TO THE CUSTOMER BUT THE PROCESS STEP WAS MISSED BY THE SERVICE TECHNICIAN. IT SHOULD BE NOTED THAT IT IS NOT POSSIBLE TO TURN ALL ALARM FUNCTIONS OFF. THE SERVICE CENTER HAS MODIFIED THEIR PROCEDURES AND A CAPA HAS BEEN INITIATED BY THE MANUFACTURER TO PREVENT THIS ERROR FROM HAPPENING AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118454 PRECISION FLOW PRECISION FLOW CAX VAPOTHERM, INC. PF-UNIT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other