BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KCI 3M WOUND VAC ULTA NWPT

    MDR report key: 12016607 · Received June 16, 2021

    Report

    Report Number
    MW5101943
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    February 12, 2021
    Report Date
    June 14, 2021
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL WOUND VAC ULTA PUMP NOT FUNCTIONING AT TIME OF ASSESSMENT. WOUND VAC MACHINE INDICATED "FUNCTIONING AT 125 MMHG", NO ALARMS. WITH REMOVAL OF KERLIX DRESSING TO FOOT, BLACK FOAM DRESSING NOT COMPRESSED. WITH SEPARATION OF TUBING FROM PT AND WOUND VAC MACHINE AND THEN REMOVAL OF CANISTER FROM MACHINE, THERE CONTINUED TO BE NO ALARM AND MACHINE INDICATED "FUNCTIONING AT 125 MMHG. CS CONTACTED FOR NEW VAC ULTA MACHINE, CONNECTED NEW MACHINE TO PT. (B)(6), KCI WOUND VAC REPRESENTATIVE WAS ON THE UNIT TO CHECK IN WITH THIS RN ONCE ADVISED BY CS THAT MACHINE HAD MALFUNCTIONED. ALL DETAILS OF FOUND MALFUNCTIONING MACHINE DISCUSSED WITH KCI REP. UNCLEAR HOW LONG MACHINE NOT FUNCTIONING, WOUND DID LOOK IMPROVED FROM (B)(6) 2021 ASSESSMENT, NO CONCERN FOR DETERIORATING WOUND DUE TO MACHINE MALFUNCTION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902799 KCI 3M WOUND VAC ULTA NWPT NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP KCI USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR