BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL BB 100 HEAT & MOISTURE EXCHANGER FILTER

    MDR report key: 120924 · Received September 19, 1997

    Report

    Report Number
    2432733-1997-00042
    Event Type
    Other
    Date Received
    September 19, 1997
    Date of Event
    August 15, 1997
    Report Date
    August 22, 1997
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO.
    Product Code
    CAH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION/ANALYSIS: THE RETURNED DEVICE WAS ANALYZED IN THE FIRM'S LABORATORY AND FOUND TO HAVE A RESISTANCE LEVEL WITHIN THE SPECIFICATION FOR NEW PRODUCT. NO OTHER DEVIATIONS FROM NORMAL PRODUCT WAS APPARENT. THE DEVICE DID NOT MALFUNCTION. THE FIRM IS UNABLE TO RECONFIRM THE NATURE OF THE USER'S RPT WITH ITS OWN FINDINGS. THE CAUSE OF THE EVENT REMAINS INDETERMINATE.

    Description of Event or Problem · 1

    FOUR DEVICES WERE NOTED TO BLOCK DURING NEBULIZATION OF 5 MG OF SALBUTAMOL IN SALINE SOLUTION. A DECREASE IN THE PT'S TIDAL VOLUME WAS NOTED AND THE DEVICES WERE REMOVED. THERE WAS NO REPORTED ADVERSE EFFECTS DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL BB 100 HEAT & MOISTURE EXCHANGER FILTER HEAT & MOISTURE EXCHANGE CAH PALL BIOMEDICAL PRODUCTS CO. BB100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention