BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS TCH DEVICE&POWER SPLY

    MDR report key: 8765823 · Received July 6, 2019

    Report

    Report Number
    8043484-2019-00453
    Event Type
    Malfunction
    Date Received
    July 6, 2019
    Date of Event
    June 6, 2019
    Report Date
    January 16, 2020
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    PMA / PMN Number
    K153209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SMITH AND NEPHEW HAS NOW CONCLUDED THE INVESTIGATION FOR THIS COMPLAINT. THE DEVICE INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. WITHOUT THIS ASSESSMENT WE ARE UNABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE REPORTED COMPLAINT AND THE DEVICE. A ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE. THE MANUFACTURING RECORDS HAVE BEEN REVIEWED AND THERE WERE NO ISSUES AT THE POINT OF RELEASE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE COMPLAINT HISTORY FOR THE PRECEDING FOUR YEARS FOUND OTHER INSTANCES OF THIS REPORTED ISSUE, THESE INSTANCES ARE BEING MONITORED TO DETERMINE IF ADDITIONAL ACTIONS ARE REQUIRED. ALARM THRESHOLDS ARE SET AFTER THOROUGH TESTING AND WE ALWAYS SET THEM TO ENSURE THE COMPLETE SAFETY OF THE PATIENT. IT IS POSSIBLE IN EXTREME CASES THAT THE ALARM MAY TRIGGER INADVERTENTLY. IN THIS INSTANCE THERAPY WILL STILL BE DELIVERED. SHOULD ADDITIONAL INFORMATION, OR THE DEVICE, BE RECEIVED THIS COMPLAINT WILL BE REOPENED AND REEVALUATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TREATMENT A LEAK OCCURRED AND THE DRESSING WAS NOT COMPRESSED. NO PATIENT HARM REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT ALARM (C-0250878) WHEN LEAK OCCURRED (C-0251828). NO PATIENT AFFECTATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559506 RENASYS TCH DEVICE&POWER SPLY NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. KTAG160548

    Patients

    Seq Age Sex Outcome Treatment
    1