BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V.A.C. THERAPY

    MDR report key: 1233447 · Received November 9, 2008

    Report

    Report Number
    1233447
    Event Type
    Malfunction
    Date Received
    November 9, 2008
    Date of Event
    September 4, 2008
    Report Date
    November 9, 2008
    Manufacturer
    KINETIC CONCEPTS, INC. (KCI)
    Product Code
    JCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON HOURLY ROUNDING ON PATIENT, BEDSIDE NURSE NOTICED THAT THE WOUND VAC WAS NO LONGER ON. WITH ADDITIONAL INVESTIGATION, IT WAS NOTICED THAT THE WOUND VAC STATED "BATTERY CRITICAL" THEN TURNED OFF DESPITE BEING PLUGGED INTO THE WALL FROM THE TIME THE NIGHT NURSE DID FIRST ASSESSMENT AND SUBSEQUENT HOURLY ROUNDING. NEW WOUND VAC ORDERED, RECEIVED AND THERAPY RE-INITIATED.======================MANUFACTURER RESPONSE FOR WOUND VAC PUMP, WOUND VAC PUMP======================KCI INVESTIGATING. OUR IN-HOUSE BIOMED TESTED THE WOUND-VAC.REMOVED BATTERY PACK, TERMINAL VOLTAGE MEASURED 13.07 VDC WHERE BATTERY VOLTAGE WAS LABELED 14.7 AT FULL CHARGE. REINSTALLED BATTERY PACK, ERROR NO LONGER APPEARED AND BATTERY CHARGING ICON WAS DISPLAYING. DEVICE SEEMS TO BE BATTERY DEPENDENT EVEN WHEN ON LINE POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V.A.C. THERAPY PUMP, WOUND CARE DEVICE JCX KINETIC CONCEPTS, INC. (KCI) 60090 *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR