BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON PROCKETPEAK, PEAK FLOW METER, UNIVERSAL RA

    MDR report key: 3837842 · Received April 1, 2014

    Report

    Report Number
    1044475-2014-00097
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE PEAK FLOW METER IS NOT MEASURING FLOW ON THE PATIENT'S EXPIRATORY VOLUME. THE FLOW INDICATOR STICKS AND SOMETIMES THE FLOW ARROW FALLS OFF. ANOTHER DEVICE WAS USED ON THE PATIENT. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193078 HUDSON PROCKETPEAK, PEAK FLOW METER, UNIVERSAL RA PEAK FLOW METER BZH TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1