BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINIELITE COMPRESSOR NEBULIZER SYSTEM

    MDR report key: 2624739 · Received January 12, 2010

    Report

    Report Number
    2243193-2010-00001
    Event Type
    Other
    Date Received
    January 12, 2010
    Date of Event
    December 11, 2009
    Report Date
    January 11, 2010
    Manufacturer
    RESPIRONICS NEW JERSEY, INC.
    Product Code
    CAF
    PMA / PMN Number
    K060404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ALLEGES THAT THE COMPRESSOR STOPPED WORKING AND, AS A RESULT, TREATMENT IN THE EMERGENCY ROOM WAS REQUIRED. THE DEVICE WAS INSPECTED AND FOUND TO BE OPERATING WITHIN SPECIFICATION AND THE CONDITION DESCRIBED BY THE USER COULD NOT BE DUPLICATED. THERE WILL BE CONTINUED MONITORING OF RELATED COMPLAINTS FOR THIS PRODUCT.

    Description of Event or Problem · 1

    THE PATIENT ALLEGES THAT THE COMPRESSOR STOPPED WORKING TWICE DURING TREATMENTS AND NEEDED TO BE TREATED AT THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIELITE COMPRESSOR NEBULIZER SYSTEM NEBULIZER COMPRESSOR CAF RESPIRONICS NEW JERSEY, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention