BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO

    MDR report key: 11836102 · Received May 17, 2021

    Report

    Report Number
    8043484-2021-01147
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 29, 2021
    Report Date
    June 28, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    UDI-DI
    00040565126944
    PMA / PMN Number
    K152163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, INTENDED TO BE USED IN TREATMENT, HAS BEEN RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND SHOWED THE HOUSING IS DAMAGED. THE DOOR FLAP AND THE INLET IS BROKEN. A BAD ODOR WAS REPORTED. THE FUNCTIONAL INSPECTION FOUND THAT THE DEVICE COULD NOT MAINTAIN PRESSURE, ESTABLISHING A RELATIONSHIOP BETWEEN THE DEVICE AND THE REPORTED EVENT. THE ROOT CAUSE WAS IDENTIFIED AS A DEFECTIVE VACUUM MOTOR AND CONTACT WITH ANOTHER SOURCE A REVIEW OF THE ASSOCIATED BATCH MANUFACTURING RECORDS CONFIRMED THAT THE DEVICE MET MANUFACTURING SPECIFICATIONS AT THE POINT OF RELEASE. A COMPLAINT HISTORY REVIEW FOUND FURTHER INSTANCES OF THE REPORTED EVENT. THIS INVESTIGATION IS NOW COMPLETE WITH NO FURTHER ACTION DEEMED NECESSARY. WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE. SMITH + NEPHEW ACKNOWLEDGE CUSTOMER CONCERN AND ARE CONTINUALLY INVESTIGATING WAYS TO DEVELOP AND IMPROVE OUR PRODUCTS.

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RENASYS GO DOES NOT GENERATE/CONTROL NEGATIVE PRESSURE AND THE CASE IS CRACKED. AS THIS WAS NOTICED ON SERVICE AND REPAIR OPERATIONS, NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733828 RENASYS GO NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. 66801496 00040565126944

    Patients

    Seq Age Sex Outcome Treatment
    1