BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO

    MDR report key: 10538647 · Received September 15, 2020

    Report

    Report Number
    8043484-2020-02875
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 6, 2020
    Report Date
    October 5, 2020
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    PMA / PMN Number
    K152163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED BY THE CUSTOMER HAS IDENTIFIED THAT THIS EVENT HAS BEEN ALREADY REPORTED UNDER 8043484-2020-02697. THE NEW INFORMATION CONFIRMS THAT THIS IS A DUPLICATE COMPLAINT, THEREFORE, IF FURTHER DETAILS ARE PROVIDED IN FUTURE CONFIRMING THE OPPOSITE, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT WILL BE SUBMITTED OUTLINING BOTH EVENTS DETAILS AND OUR INVESTIGATIONS PERFORMED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED BY THE CUSTOMER HAS IDENTIFIED THAT THIS EVENT HAS BEEN ALREADY REPORTED UNDER 8043484-2020-02875. THE NEW INFORMATION CONFIRMS THAT THIS IS A DUPLICATE COMPLAINT, THEREFORE, IF FURTHER DETAILS ARE PROVIDED IN FUTURE CONFIRMING THE OPPOSITE, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT WILL BE SUBMITTED OUTLINING BOTH EVENTS DETAILS AND OUR INVESTIGATIONS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT IS OVERHEATING. NO PROCEDURE WAS BEING PERFORMED. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001308 RENASYS GO NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1