BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 522042 · Received February 6, 2004

    Report

    Report Number
    522042
    Event Type
    Other
    Date Received
    February 6, 2004
    Date of Event
    October 1, 2003
    Report Date
    November 1, 2003
    Manufacturer
    WESTMED, INC.
    Product Code
    BZE
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT'S FAMILY MEMBER NOTIFIED THE FACILITY CONCERNING A TRACH CIRCUIT (TUBING) THAT HAD MELTED IN ONE SPOT. FAMILY MEMBER SAID THAT ONE TUBING HAD MELTED AND FAMILY MEMBER CHANGED IT OUT AND THE SECOND TUBING WAS BEGINNING TO MELT. THE CIRCUITS WERE WESTMED. A TOTAL OF 3 CIRCUITS WITH THE SAME LOT # MELTED. THE FACILITY PICKED UP ALL THE CIRCUITS WITH THAT LOT # FROM THE PT'S HOME AS WELL AS ANY FROM THE WAREHOUSE AND TOOK THEM OUT OF SERVICE. CO RE-ORDERED CIRCUITS AND RECEIVED A LETTER STATING THAT THE CIRCUIT WOULD BE A CORRECT MATCH FOR THE HEATING SYSTEM CURRETNLY IN USE ON THIS PT. THERE HAVE BEEN NO FURTHER INCIDENTS OF OVER-HEATED CIRCUITS. COMPANY DOES NOT THINK THIS WAS USER ERROR. SINCE THIS INCIDENT, COMPANY HAS LEARNED THAT WHEN YOU CONNECT ANY HEATED WIRE CIRCUIT TO A HEATHER, THE AMPERAGE, WATTAGE, ETC. MUST BE CORRECT AND WITH THIS PARTICULAR CIRCUIT IT WASN'T CLEARLY STATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PEDIATRIC HEATED WIRE CIRCUIT BZE WESTMED, INC. * 02958

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO