BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON POCKET PEAK, PEAK FLOW METER

    MDR report key: 2934785 · Received January 23, 2013

    Report

    Report Number
    1044475-2013-00013
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 4, 2013
    Manufacturer
    TELEFLEX
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED BY THE MANUFACTURER, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE END USER DESCRIBES THE DEVICE AS GIVING INACCURATE READINGS. AS SHE (END USER) BLOWS INTO THE METER THE BLUE INDICATOR WILL GIVE READINGS THAT RANGE FROM 350LPM TO 700LPM. SHE EXPLAINED THAT HER BREATH PRESSURE DID NOT VARY TO THAT EXTENT WHEN SHE BLEW INTO THE DEVICE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33202 HUDSON POCKET PEAK, PEAK FLOW METER PEAK FLOW METER CAF TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1