BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS EZ PLUS

    MDR report key: 3770134 · Received April 24, 2014

    Report

    Report Number
    3006760724-2014-00312
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    September 15, 2011
    Report Date
    April 23, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K082426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT STATES ¿DEVICE DOESN´T MAINTAIN PRESSURE, DOESN´T ALARM.¿ THIS ISSUE WAS NOT CONFIRMED UPON EVALUATION OF THE RETURNED DEVICE, WHICH FUNCTIONED AND ALARMED PROPERLY. SMITH & NEPHEW HAS ISSUED (B)(4) TO INITIATE RENASYS PRODUCT LABELING UPDATES. THESE LABELING 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: DEVICE DOESN´T MAINTAIN PRESSURE AND DOESN´T ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248757 RENASYS EZ PLUS PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800697

    Patients

    Seq Age Sex Outcome Treatment
    1 Other