BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDUST 2

    MDR report key: 954938 · Received November 26, 2007

    Report

    Report Number
    MW5004518
    Event Type
    Malfunction
    Date Received
    November 26, 2007
    Report Date
    November 12, 2007
    Manufacturer
    RESPIRONICS/SLEEP AND HOMECARE RESPIRATORY
    Product Code
    LEL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IF RESULTS FROM LAST PT STUDY ARE NOT MANUALLY CLEARED FROM MEMORY AND THE MEMORY IS FULL, WHEN A NEW PT STUDY IS PERFORMED, THE DEVICE ALLOWS YOU TO ENTER PT DEMOGRAPHIC INFO FOR THE NEW PT, BUT DOES NOT RECORD ANY NEW TEST RESULTS. WHEN YOU PRINT OUT A REPORT, YOU GET THE CORRECT PT DEMOGRAPHIC INFO, BUT THE RESULTS FOR THE STUDY ARE FOR THE LAST PT THAT THE DEVICE WAS ABLE TO FIT INTO THE MEMORY. IF THE USER IS NOT PAYING CLOSE ATTENTION, THEY PRESUME THAT SINCE THE PT IDENTIFIER INFO ON THE PRINTOUT IS CORRECT, THAT THEY HAVE THE CORRELATING TEST RESULTS ON THE PRINTOUT WHEN THIS IS NOT THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARDUST 2 PORTABLE SLEEP STUDY SCREENING RECORDER LEL RESPIRONICS/SLEEP AND HOMECARE RESPIRATORY STARDUST 2

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other