BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL ULTIPOR 100 BREATHING SYSTEM FILTER

    MDR report key: 1891169 · Received November 4, 2010

    Report

    Report Number
    9680602-2010-00011
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 19, 2010
    Manufacturer
    PALL NEWQUAY
    Product Code
    CAH
    PMA / PMN Number
    K791307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: NO DIRECT INVESTIGATION WAS POSSIBLE SINCE THE REPORTER DID NOT RETURN THE INVOLVED DEVICES. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY DEVIATIONS THAT WOULD RELATE TO THE USER'S REPORT. IN GENERAL, THE POTENTIAL FOR AIR FLOW RESTRICTION IN THE MODEL DEVICE HAS BEEN RECOGNIZED. THE DEVICE LABELING REFERS TO THE POTENTIAL OF SUCH BLOCKAGE IN THE INSTRUCTIONS FOR USE AS PRECAUTIONS: "RARELY AN INCREASED AIRFLOW RESISTANCE OCCURS WITH LIQUID DRUG NEBULIZATION WHICH MANDATES VIGILANCE," AND "VENTILATOR ALARMS SHOULD BE IN USE AT ALL TIMES." FROM THE INFORMATION PROVIDED BY THE USER, THESE PRECAUTIONS WERE OBSERVED BY THE USER, AND THE DEVICES THAT WERE REPORTED TO BECOME OCCLUDED DURING USE WERE CHANGED OUT FOR FRESH DEVICES, AND THERE WERE NO REPORTED ADVERSE EFFECTS EXPERIENCED BY THE PATIENT. SUMMARY: NO DIRECT INVESTIGATION WAS POSSIBLE; IT WAS NOT POSSIBLE TO CONFIRM ANY DEVICE MALFUNCTION. HOWEVER, THE DEVICE APPEARS TO HAVE PERFORMED ACCORDING TO EXPECTATIONS. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOCKAGE OCCURRED IN THREE DEVICES USED ON A TOTAL OF TWO PATIENTS.NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL ULTIPOR 100 BREATHING SYSTEM FILTER BREATHING CIRCUIT FILTER CAH PALL NEWQUAY BB100AF 008502

    Patients

    Seq Age Sex Outcome Treatment
    1