BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE MINISPACER MDI ADAPTER

    MDR report key: 2403916 · Received December 5, 2011

    Report

    Report Number
    2026894-2011-00001
    Event Type
    Malfunction
    Date Received
    December 5, 2011
    Date of Event
    October 31, 2011
    Report Date
    December 2, 2011
    Manufacturer
    THAYER MEDICAL CORP.
    Product Code
    BZA
    PMA / PMN Number
    K955805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED TO THE MFR TWO, UNOPENED SAMPLES FROM THE ABOVE LISTED LOT NUMBERS. THE CUSTOMER COULD NOT CONFIRM WHICH LOT NUMBER WAS INVOLVED IN THE REPORTED EVENT. SAMPLES FROM BOTH LOT NUMBERS WERE EVALUATED AND THE FAILURE COULD NOT BE REPRODUCED UNDER SIMULATED USE CONDITIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT CAP OF THE MDI ADAPTER DOES NOT STAY ON. CUSTOMER STATED THAT BECAUSE OF THIS ISSUE, A PT WAS NOT GETTING HIS VOLUMES. DUE TO PULMONARY HYPERTENSION AND OTHER CONDITIONS, THE PT WAS CONCURRENTLY RECEIVING NITRIC OXIDE THROUGH A INOMAX DS MACHINE CONNECTED TO THE PURITAN BENNETT 840 VENTILATOR CIRCUIT. INOMAX WOULD ALARM DUE TO THE VOLUME LOSS AS A RESULT OF THE MDI ADAPTER CAP POPPING OFF. CUSTOMER REPORTED THAT THE INOMAX STOPPED DELIVERING NITRIC OXIDE AUTOMATICALLY BECAUSE OF THE LOW VOLUME DELIVERY. PT STARTED TO DESATURATE. THERAPIST TAPED CAP ON MDI ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRLIFE MINISPACER MDI ADAPTER ACTUATOR BZA THAYER MEDICAL CORP. 002091D 110616, 110509

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR COMBIVENT VIA THE MDI ADAPTER| PURITAN BENNETT 840| THE VENTILATOR| NITRIC OXIDE VIA INOMAX DS CONNECTED TO