BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS EZ PLUS

    MDR report key: 3895411 · Received June 25, 2014

    Report

    Report Number
    3006760724-2014-00388
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    March 14, 2014
    Report Date
    November 18, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K102001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION RECEIVED AS OF TODAY.

    Description of Event or Problem · 1

    FAILURE TO CHARGE RENASYS EZ PLUS ARE "DYING" WHEN YOU DISCONNECT THEM FROM MAIN POWER.

    Description of Event or Problem · 1

    FAILURE TO CHARGE RENASYS EZ PLUS ARE "DYING" WHEN YOU DISCONNECT THEM FROM MAIN POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369988 RENASYS EZ PLUS RENASYS EZ PLUS BTA SMITH & NEPHEW WOUND MANAGEMENT 66800697

    Patients

    Seq Age Sex Outcome Treatment
    1