BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS EZ PLUS

    MDR report key: 3952693 · Received July 23, 2014

    Report

    Report Number
    3006760724-2014-00399
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    March 17, 2014
    Report Date
    July 22, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    OMP
    PMA / PMN Number
    K102001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IN PROGRESS; RESULTS OF INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENT REPORT.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION, AND SERIAL NUMBER WAS NOT PROVIDED. NO EVALUATION POSSIBLE.

    Description of Event or Problem · 1

    FAILURE TO ALARM. NEGATIVE PRESSURE WOUND THERAPY MACHINE FAILED TO ALARM WHEN THERE WAS A LEAK; LIQUID STOOL ENTERED THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431259 RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW WOUND MANAGEMENT 66800697

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR