BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE

    MDR report key: 3913237 · Received May 9, 2014

    Report

    Report Number
    1419652-2014-00127
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARJOHUNTLEIGH HAVE BEEN INFORMED THAT WHILST THE BREEZE PUMP WAS BEING HUNG ON THE END OF THE BED, THE HANGING BRACKET BROKE AND THE PUMP LANDED ON THE NURSE FOOT. THE OVERALL OUTCOME WAS FOOT SWOLLEN AND BRUISED. THE PUMP AND BRACKET WERE REMOVED FROM THE PUMP AND RETURN TO THE DEPOT. MFR - 1000381138-2014-00007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281209 BREEZE FNM ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB 625301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other