BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROLAB II

    MDR report key: 4187961 · Received September 30, 2014

    Report

    Report Number
    4187961
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 29, 2014
    Manufacturer
    SDI DIAGNOSTICS, INC.
    Product Code
    BZG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE MACHINE WOULD NOT REGISTER WHEN THE PATIENT BLEW INTO THE TURBINE. UNABLE TO GET RESULTS WHEN ATTEMPTING TESTING ON PATIENT. PATIENT WAS TRANSFERRED TO SISTER FACILITY WHERE TESTING WAS COMPLETED.======================MANUFACTURER RESPONSE FOR SPIROMETER, SPIROLAB II (PER SITE REPORTER).======================THE DISPLAY, BATTERY PACK, MAIN PCB CONNECTOR, CABLE CONNECTOR, CABLE COVER AND MOUTHPIECE HOLDER NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606759 SPIROLAB II SPIROMETER BZG SDI DIAGNOSTICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *