BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO V2

    MDR report key: 4221033 · Received November 3, 2014

    Report

    Report Number
    3006760724-2014-00437
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    OMP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POWER CONNECTION IS BREAKING ACCORDING TO THE CUSTOMER, THE CONNECTION BURNT, THERE WAS LIKE ¿SMOKE¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703072 RENASYS GO V2 NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW, INC. 66801244 KABG130428

    Patients

    Seq Age Sex Outcome Treatment
    1