BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS EZ MAX, HOSPITAL

    MDR report key: 3870473 · Received June 12, 2014

    Report

    Report Number
    3006760724-2014-00386
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 16, 2014
    Report Date
    December 16, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K132446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IN PROGRESS; RESULTS OF INVESTIGATION WILL BE SUBMITTED IN A SUPPLEMENT REPORT.

    Description of Event or Problem · 1

    THERE WAS POOLING AROUND THE WOUND SIDE AND NO ALARMS.

    Description of Event or Problem · 1

    THERE WAS POOLING AROUND THE WOUND SIDE AND NO ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348305 RENASYS EZ MAX, HOSPITAL RENASYS EZ MAX, HOSPITAL BTA SMITH & NEPHEW WOUND MANAGEMENT 66801309

    Patients

    Seq Age Sex Outcome Treatment
    1 Other