BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASTERSCOPE PFT

    MDR report key: 897740 · Received August 20, 2004

    Report

    Report Number
    2050001-2004-00028
    Event Type
    Malfunction
    Date Received
    August 20, 2004
    Date of Event
    July 29, 2004
    Report Date
    August 20, 2004
    Manufacturer
    SENSORMEDICS
    Product Code
    BZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASTERSCOPE PFT RESPIRATORY DIAGNOSTIC BZM SENSORMEDICS OXYCON ALPHA *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR