BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOUND VAC

    MDR report key: 1348758 · Received March 14, 2009

    Report

    Report Number
    1348758
    Event Type
    Malfunction
    Date Received
    March 14, 2009
    Date of Event
    February 10, 2009
    Report Date
    March 14, 2009
    Manufacturer
    KINETIC CONCEPTS, INC.
    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

    PUMP ALARMING "CANISTER NOT ENGAGED." HOWEVER, THE CANISTER WAS NEVER MOVED, NOR WAS IT TOUCHED IN ANYWAY SINCE THE PT ARRIVED BACK FROM OR. SEVERAL ATTEMPTS WERE MADE TO TAKE OUT AND RE-PLACE THE CANISTER WITHOUT SUCCESS IN FIXING THE ALARM, ALSO AN ELECTRICAL CORD WAS FOUND AND CLEANED AND ENGAGED TO WOUND VAC WITHOUT SUCCESS. SEVERAL ATTEMPTS AT TURNING WOUND VAC ENTIRELY OFF THEN ON AGAIN ALSO DID NOT FIX THE ALARM. ANOTHER WOUND VAC WAS SECURED AND THIS WOUND VAC WAS REPLACED. ====================== MANUFACTURER RESPONSE FOR WOUND VAC, WOUND VAC======================WOUND VACS ARE RENTAL DEVICES FROM KCI. KCI MAINTAINS WOUND VACS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOUND VAC WOUND THERAPY SYSTEM JCX KINETIC CONCEPTS, INC. 60090 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR