BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PED 5 FT DUAL-HTD CIRCUIT

    MDR report key: 943306 · Received April 18, 2007

    Report

    Report Number
    1423507-2007-00034
    Event Type
    Malfunction
    Date Received
    April 18, 2007
    Date of Event
    March 10, 2007
    Report Date
    April 11, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    BZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY THE SAMPLE WAS THROWN OUT BY THE CUSTOMER, THEREFORE WE ARE UNABLE TO DETERMINE THE EXACT CAUSE FOR THE REPORTED ISSUE. HOWEVER, SAMPLES OF THE PROCESS WERE REVIEWED AND NO PROBLEMS WERE FOUND RELATED TO THE ISSUE REPORTED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED EITHER SINCE A LOT NUMBER WAS NOT REPORTED BY THE CUSTOMER. THE PRODUCT LABEL DOES INDICATE THAT OBJECTS SUCH AS HEAVY TAPES, TOWELS OR BED LINENS MAY OVER INSULATE THE CIRCUITS, IMPEDE NORMAL HEAT CONVECTION, AND CAUSE DAMAGE TO THE TUBING OR INTERRUPTION OF GAS DELIVERY TO THE PATIENT SUCH AS IN THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT A HOLE WAS BURNED ON THE EXPIRATORY LIMB, ABOUT 12 INCHES FROM THE PATIENT EYE. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PED 5 FT DUAL-HTD CIRCUIT PED 5 FT DUAL-HTD CIRCUIT BZB CARDINAL HEALTH RT509-852 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other