BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMIDIFLOW

    MDR report key: 842894 · Received April 26, 2007

    Report

    Report Number
    2132517-2007-00001
    Event Type
    Malfunction
    Date Received
    April 26, 2007
    Date of Event
    April 10, 2007
    Report Date
    April 25, 2007
    Manufacturer
    POROUS MEDIA CORP.
    Product Code
    BTT
    PMA / PMN Number
    K062091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    CAPA IMPLEMENTED BY MFR TO ADDRESS THIS ISSUE: MFR HAS DESIGNED A FILTER RESTRAINT DEVICE THAT CAN BE EASILY INSTALLED TO THE INTAKE FILTER OF THIS HUMIDIFLOW KIT TO ELIMINATE THE POTENTIAL FOR THE INTAKE FILTER TO BECOME DISCONNECTED FROM THE HUMIDIFLOW. POROUS MEDIA WILL NOTIFY ALL CUSTOMERS BY LETTER WHO HAVE RECEIVED A P/N HKM-RM AND PROVIDE THEM WITH A CORRECTION KIT WHICH INCLUDES ONE OF THE INTAKE FILTER RESTRAINT DEVICES AND REQUIRED INSTALLATION INSTRUCTIONS (COPY OF THE LETTER, INSTRUCTIONS, AND CUSTOMER LIST ATTACHED). MFR HAS REVISED THE DMR FOR THIS PRODUCT TO INCLUDE THE NEW FILTER RESTRAINT DEVICE THAT WILL BE INCLUDED ON ALL NEWLY MFG HUMIDIFLOW KIT P/N'S HMK-RM PRODUCED BY MFR . MFR HAS UPDATED THE DMR FOR THIS PRODUCT TO INCLUDE A REVISED INSTALLATION MANUAL THAT INCLUDES INFO REGARDING USAGE OF THE FILTER RESTRAINT DEVICE, AND THE REQUIREMENTS FOR REINSTALLATION OF THE FILTER RESTRAINT DEVICE EACH TIME THE INTAKE FILTER IS REPLACED. UPDATED THE DHF FOR THIS PRODUCT TO INCLUDE A REVISION TO THE PRODUCT RISK ASSESSMENT ACCORDING TO OUR RISK MGMT PROCEDURAL REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR THAT THE INTAKE FILTER FROM ONE OF HUMIDIFLOW KITS (RESPIRATORY GAS HUMIDIFIER) SPECIFICALLY USED ON A RESPIRONICS MILLENNIUM OXYGEN CONCENTRATOR BECAME DETACHED DURING PT TREATMENT. DURING USE, THE INTAKE FILTER BECAME DISCONNECTED FROM THE HUMIDIFLOW AND FELL ONTO THE OXYGEN CONCENTRATORS INTERNAL COOLING FAN. THE FILTER BECAME LODGED IN THE FAN'S VANES CAUSING THE FAN TO STOP, RESULTING IN THE CONCENTRATOR OVERHEATING AND SHUTTING DOWN CEASING THE FLOW OF OXYGEN TO THE PT. NO HARM TO THE PT OR CONCENTRATOR WAS REPORTED. THE INTAKE FILTER WAS THEN REINSTALLED BY THE RESPIRATORY THERAPIST AND THE PT CONTINUED THEIR TREATMENT WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMIDIFLOW RESPIRATORY GAS HUMIDIFIER BTT POROUS MEDIA CORP. HMK-RM 072849001

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other