BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1604099 · Received February 10, 2010

    Report

    Report Number
    1625774-2010-00015
    Event Type
    Malfunction
    Date Received
    February 10, 2010
    Date of Event
    December 6, 2009
    Report Date
    December 6, 2009
    Manufacturer
    KCI USA, INC
    Product Code
    OMP
    PMA / PMN Number
    K063740
    Removal / Correction Number
    1625774-10/28/2009-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURES ON (B)(6)2009, PRIOR TO DELIVERY TO THE ACCOUNT, AND MET SPECIFICATIONS. SUBSEQUENT TO THE REPORTED EVENT, A REPLACEMENT POWER CORD WAS PROVIDED TO THE PT. THE ORIGINAL POWER CORD WAS NOT RETURNED TO KCI FOR EVALUATION. THE ACTIV.A.C. THERAPY UNIT REMAINED WITH THE PT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER CORD PLUG ALLEGEDLY SPARKED WHILE PLUGGED INTO THE WALL OUTLET. THE ACTIV.A.C. THERAPY UNIT WAS INITIALLY PLACED WITH THE ACCOUNT ON (B)(6)2009. THERE WAS NO REPORT OF AN INJURY TO THE PT OR CAREGIVER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1