BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO RENTAL DEVICE

    MDR report key: 4305841 · Received December 8, 2014

    Report

    Report Number
    3006760724-2014-00445
    Event Type
    Malfunction
    Date Received
    December 8, 2014
    Date of Event
    November 14, 2014
    Report Date
    May 18, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    OMP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    FAILURE TO ALARM; THE PHN HAD COMPLAINED OF NO ALARM OCCURING. DESPITE POOLING OF FLUID UNDER DRAPE. PHN USING CHANNEL DRAIN AND THEN HAD TO CHANGE TO ROUND DRAIN AS PRODUCT SHORTAGE. IT WAS WITH THE ROUND DRAIN THAT POOLING OCCURED AND NO ALARM. PATIENT CURRENTLY BACK ON CHANNEL DRAIN NO COMPLAINTS OF POOLING.

    Description of Event or Problem · 1

    FAILURE TO ALARM; THE PHN HAD COMPLAINED OF NO ALARM OCCURING. DESPITE POOLING OF FLUID UNDER DRAPE. PHN USING CHANNEL DRAIN AND THEN HAD TO CHANGE TO ROUND DRAIN AS PRODUCT SHORTAGE. IT WAS WITH THE ROUND DRAIN THAT POOLING OCCURED AND NO ALARM. PATIENT CURRENTLY BACK ON CHANNEL DRAIN NO COMPLAINTS OF POOLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791092 RENASYS GO RENTAL DEVICE NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW, INC. 66800164R KGTE110198

    Patients

    Seq Age Sex Outcome Treatment
    1