BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUSTIN HEALTHMATE PLUS

    MDR report key: 206037 · Received January 13, 1999

    Report

    Report Number
    MW1015437
    Event Type
    Other
    Date Received
    January 13, 1999
    Date of Event
    January 1, 1995
    Report Date
    January 13, 1999
    Manufacturer
    AUSTIN AIR SYSTEMS, INC.
    Product Code
    FRF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR PURCHASED 2 AIR PURIFIERS IN 1993 AND ONE IN 1994; ALL THREE WERE MFG IN 1993. CALLER REPORTS THAT SHE HAS HAD ONGOING PROBLEMS WITH THE DEVICES NOT WORKING WELL AND DELIVERING POOR AIR QUALITY. RPTR HAS SPENT HUNDREDS OF DOLLARS ON THE DEVICES THEMSELVES, AS WELL AS EXPENSES IN PURCHASING NEW AIR FILTERS. THE DEVICES HAVE A 5 YEAR WARRENTY. RPTR CLAIMS THAT SHE REPLACES THE AIR FILTERS TO GET PURER AIR, HOWEVER SHE CAN NOT GET FILTERS FOR THE 1993 MODEL. INSTEAD SHE WAS GIVEN 1994 MODEL AIR FILTERS THAT ACTUALLY BREAK OPEN AND DELIVER PARTICLES INTO THE AIR. THE DEVICES ARE COVERED IN BLACK CARBON. RPTR ATTRIBUTES USE OF THESE DEVICES TO A RECENT BRONCHITIS INFECTION. RPTR HAS CONTACTED THE MFR MULTIPLE TIMES REGARDING THE WARRANTY, QUALITY AND THE EXPENSE, HOWEVER RPTR CLAIMS THAT THE MFR OFFERED TO COLLECT THE DEVICES AND SEND NEW ONES FOR PAYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUSTIN HEALTHMATE PLUS AIR PURIFIER FRF AUSTIN AIR SYSTEMS, INC. 393639 *
    2 AUSTIN HEALTHMATE PLUS AIR PURIFIER FRF AUSTIN AIR SYSTEMS, INC. 9304221 *
    3 AUSTIN HEALTHMATE PLUS AIR PURIFIER FRF AUSTIN AIR SYSTEMS, INC. 393640 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other