BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO

    MDR report key: 1962547 · Received December 29, 2010

    Report

    Report Number
    1962547
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 23, 2010
    Report Date
    December 29, 2010
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    OMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED IN OPERATING ROOM. SURGEON NOTICED PUMP READING 120MM/HG OF PRESSURE BUT WOUND THERAPY BAG NOT COMPRESSED AT ALL. NO ALARMS SOUNDING, DRESSING WELL SEALED. A DRAINAGE HAD ACCUMULATED ALL AROUND THE WOUND. SURGEON TESTED UNIT BY DETACHING TUBING & STILL NO ALARMS. QUESTIONABLE IF WOUND WOULD HAVE HEALED BETTER IF PUMP WORKING AS IT SHOULD BUT COULD NOT DETERMINE. IT IS BELIEVED TO HAVE BEEN FUNCTIONING CORRECTLY LAST SEEN THAT AFTERNOON. NOTED NOT TO BE WORKING IN OR APPROXIMATELY 3 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENASYS GO NEGATIVE PRESSURE WOUND THERAPY OMP SMITH & NEPHEW, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR NO OTHER THERAPIES