BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON INCENTIVE SPIROMETER

    MDR report key: 2447285 · Received January 30, 2012

    Report

    Report Number
    3004365956-2012-00029
    Event Type
    Malfunction
    Date Received
    January 30, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 13, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: "COMPLAINT ALLEGES THAT THE MOUTHPIECES ARE BROKEN AND CRACKED. THE ALLEGED DEFECT WAS CONFIRMED DURING INCOMING INSPECTION." NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON INCENTIVE SPIROMETER SPIROMETER BWF TELEFLEX MEDICAL 02J1001994

    Patients

    Seq Age Sex Outcome Treatment
    1