BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1634522 · Received March 10, 2010

    Report

    Report Number
    1625774-2010-00020
    Event Type
    Malfunction
    Date Received
    March 10, 2010
    Date of Event
    February 16, 2010
    Report Date
    February 16, 2010
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K062227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT THE POWER CORD SPARKED WHEN PLUGGED INTO WALL OUTLET. THE UNIT WAS RETURNED TO KCI AND TESTED AND MET SPECIFICATIONS HOWEVER, THE POWER CORD WAS NOT RETURNED TO KCI FOR EVALUATION AS IT WAS DISCARDED BY THE CUSTOMER. THE UNIT, INCLUDING POWER CORD, WAS TESTED PER QUALITY CONTROL PROCEDURES AND MET SPECIFICATIONS BEFORE BEING DELIVERED FOR PLACEMENT ON THE PATIENT. THIS DEVICE WAS INITIALLY PLACED WITH THE CUSTOMER ON (B)(6)2010. THERE WAS NO INJURY REPORTED. THE CLAIM THAT THE POWER CORD SPARKED, THE CAUSE NOR THE SOURCE COULD BE DETERMINED BASED ON THE INFORMATION PROVIDED. OTHER CAUSES, INCLUDING MISUSE, ABUSE OR POWER SOURCE, COULD NOT BE RULED OUT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1