BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDGRAPHICS PULMONARY FUNCTION

    MDR report key: 839713 · Received April 16, 2007

    Report

    Report Number
    MW5001815
    Event Type
    Malfunction
    Date Received
    April 16, 2007
    Date of Event
    January 23, 2007
    Report Date
    April 16, 2007
    Product Code
    BZM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING GAS CHROMATOGRAPH MEASUREMENT OF STUDY, PATIENT'S CELL PHONE RANG. INTERFERED WITH GAS MEASUREMENT, CAUSED SPIKES, CAUSED PREMATURE END OF MEASUREMENT, AND RESULTED IN MEASUREMENT OF 299% OF PREDICTED VALUE FOR STUDY. TEST REPEATED WITH CELL PHONE TURNED OFF, NO FURTHER COMPLICATIONS. ANOMALY WAS RELIABLY REPRODUCED USING A NEXTEL BRAND CELL PHONE -SAME BRAND AS PATIENT. ANOTHER TYPE OF CELL PHONE WAS ALSO CHECKED BUT DID NOT REPRODUCE THIS ANOMALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDGRAPHICS PULMONARY FUNCTION NONE BZM 1085 3001119

    Patients

    Seq Age Sex Outcome Treatment
    1 YR