BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS EZ PLUS

    MDR report key: 3833561 · Received May 27, 2014

    Report

    Report Number
    3006760724-2014-00367
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    March 31, 2014
    Report Date
    November 4, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K102001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION RECEIVED AS OF TODAY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    FAILURE TO ALARM. IN SURGERY, THE DRAPE HELD DOWN FINE. ONCE THE PATIENTS WAS UP AND WALKING, THE DRAPE BECAME LOOSE, YET THE EZ PLUS PUMP WOULD NOT ALARM.

    Description of Event or Problem · 1

    FAILURE TO ALARM. IN SURGERY, THE DRAPE HELD DOWN FINE. ONCE THE PATIENTS WAS UP AND WALKING, THE DRAPE BECAME LOOSE, YET THE EZ PLUS PUMP WOULD NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310273 RENASYS EZ PLUS RENASYS EZ PLUS BTA SMITH & NEPHEW WOUND MANAGEMENT 66800697

    Patients

    Seq Age Sex Outcome Treatment
    1