BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON POCKET PEAK FLOW METER

    MDR report key: 4062919 · Received August 20, 2014

    Report

    Report Number
    1044475-2014-00258
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 8, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT AVAILABLE FOR EVAL, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. BASED ON SIMILAR COMPLAINTS IN THE PAST, HOWEVER, A CAPA WAS OPENED BY THE VENDOR OF THE POCKET PEAKS TO ADDRESS THE ISSUE WITH INACCURATE READINGS. THE VENDOR ALSO REPORTED THAT ADDITIONAL CHECKS WERE MADE ON THE MOLD IN LATE 2013, AND IT WAS VERIFIED THAT THE ASSEMBLY PROCESS WAS NOT CHANGED OR MODIFIED. PRIOR TO RELEASE, THE UNITS MUST MEET MFG CRITERIA AND THEY ARE 100% TESTED BEFORE LEAVING THE FACILITY. THE VENDOR ALSO REPORTS THAT IN (B)(4) 2014 THE FORMULATION OF THE POLYPROPYLENE MATERIAL USED FOR THE BLUE MEASUREMENT INDICATOR ON THE PACKET PEAKS WAS CHANGED. THE CHANGE DOES NOT AFFECT THE FIT, FORM, FUNCTION, APPEARANCE, OR SAFETY OF THE POCKET PEAKS. THE MATERIAL CHANGE WAS MADE TO IMPROVE THE CONSISTENCY OF THE BLUE MEASUREMENT INDICATOR. IF THE SAMPLE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE POCKET PEAK FLOW METER IS GIVING AN INACCURATE READING. THE PT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503755 HUDSON POCKET PEAK FLOW METER PEAK FLOW METER BZH TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1