BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO NEGATIVE PRESSURE WOUND THERAPY

    MDR report key: 3761726 · Received April 21, 2014

    Report

    Report Number
    3006760724-2014-00201
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    July 25, 2013
    Report Date
    April 4, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K083375
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS NOT CONFIRMED, AS NO DEVICE WAS RECEIVED FOR EVALUATION. THE ROOT CAUSE FOR THE REPORTED ISSUE COULD BE ONE OF MANY RELATED TO A PUMP RESPONSE TO A CONDITION IN THE NEGATIVE PRESSURE WOUND THERAPY SYSTEM, NOT NECESSARILY CAUSED BY PUMP. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME; THE DEVICE IS NEEDED FOR EVALUATION. IT IS RECOMMENDED TO RETURN THE DEVICE FOR EVALUATION. IF THE DEVICE IS RETURNED AT A LATER DATE, THE COMPLAINT WILL BE REVIEWED AND APPROPRIATE ACTIONS WILL BE TAKEN. A REPLACEMENT WAS PROVIDED TO THE CUSTOMER TO CONTINUE WITH THE THERAPY. SMITH & NEPHEW HAS ISSUED (B)(4) TO INITIATE RENASYS PRODUCT LABELING UPDATES. THESE LABELLING UPDATES WILL PROVIDE ENHANCED INFORMATION ON THE FUNCTIONALITY OF THE ALARMS AS THEY RELATE TO THE DESIGN OF THE DEVICE, AND SCENARIOS THAT CAN OCCUR IN CLINICAL SETTINGS WHICH MAY IMPACT ALARM FUNCTIONALITY.

    Description of Event or Problem · 1

    FAILURE TO ALARM: WHEN SEAL BROKEN PUMP NOT ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241118 RENASYS GO NEGATIVE PRESSURE WOUND THERAPY PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164

    Patients

    Seq Age Sex Outcome Treatment
    1 Other