BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1329997 · Received February 28, 2009

    Report

    Report Number
    1625774-2009-00022
    Event Type
    Injury
    Date Received
    February 28, 2009
    Date of Event
    January 23, 2009
    Report Date
    January 29, 2009
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS TESTED PER QUALITY CONTROL PROCEDURES ON 12/16/08 PRIOR TO PT PLACEMENT IN 2009 AND MET SPECS. THE DEVICE WAS RETURNED FOR EVAL ON 2/12/09. WHEN THE UNIT WAS POWERED ON, AN ERROR MESSAGE WAS DISPLAYED ALONG WITH AUDIBLE AND VISUAL ALARMS. THE UNIT WAS POWERED DOWN AND BACK ON AGAIN, AND THE ERROR MESSAGE WAS GONE. A DEVICE EVAL WAS PERFORMED AND THE UNIT MET SPECS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT BEING TREATED WITH V.A.C. THERAPY IN 2009 FOR A VENOUS STASIS ULCER ON THE LEFT LOWER EXTREMITY DEVELOPED AN INFECTION AND HAD TO BE HOSPITALIZED. IT IS ALLEGED THAT DURING THE NIGHT OF ABOUT 8 DAYS LATER, THE V.A.C. THERAPY UNIT SHUT OFF AND THE PT DID NOT HEAR AN ALARM. THE HOME CARE NURSE STATED THAT THE PT RESUMED V.A.C. THERAPY AT ABOUT ONE WEEK LATER AT HOME, AND THE WOUND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V.A.C. THERAPY SYSTEM JCX KCI USA, INC. ACTIV.A.C.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention