BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO NPWT DEVICE

    MDR report key: 4121735 · Received September 26, 2014

    Report

    Report Number
    3006760724-2014-00412
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    December 11, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    OMP
    PMA / PMN Number
    K083375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FAILURE TO ALARM. PATIENTS DRESSING ALMOST OFF WOUND COMPLETELY AND DEVICE NOT ALARMING.

    Description of Event or Problem · 1

    FAILURE TO ALARM. PATIENTS DRESSING ALMOST OFF WOUND COMPLETELY AND DEVICE NOT ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601610 RENASYS GO NPWT DEVICE RENASYS GO NPWT DEVICE OMP SMITH & NEPHEW, INC. 66800164

    Patients

    Seq Age Sex Outcome Treatment
    1