BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO

    MDR report key: 10754886 · Received October 29, 2020

    Report

    Report Number
    8043484-2020-03334
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    October 16, 2020
    Report Date
    December 11, 2020
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    PMA / PMN Number
    K152163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019 THE RENASYS GO DEVICE DID NOT POWER ON. NO CASE REPORTED. A PRELIMINARY INVESTIGATION PERFORMED BY SMITH+NEPHEW ON OCT 16, 2020 SHOWED THAT THE DEVICE DISPLAYED ERROR: "DEVICE FAILED-PLEASE RETURN", CONFIRMING THIS AS A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220814 RENASYS GO NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. KHCE190456

    Patients

    Seq Age Sex Outcome Treatment
    1