BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PED 5 FT DUAL-HTD CIRCUIT

    MDR report key: 1222830 · Received November 6, 2008

    Report

    Report Number
    1423507-2008-00088
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 7, 2008
    Report Date
    November 6, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    BZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, NO SAMPLE IS AVAILABLE FOR EVAL AND INFO RECEIVED FROM THE CUSTOMER STATED THAT SHE BELIEVES THE SAMPLE HAS BEEN THROWN AWAY. HOWEVER, SAMPLES OF THE PROCESS WERE REVIEWED AND NO PROBLEMS WERE FOUND RELATED TO THE ISSUE REPORTED. A DHR REVIEW COULD NOT BE CONDUCTED SINCE NO LOT NUMBER WAS PROVIDED. BASED ON THE LIMITED INFO PROVIDED, WE ARE UNABLE TO DETERMINE THE CAUSE FOR THE ISSUE REPORTED. 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 PT SUCH AS THAT WHICH WAS REPORTED IN THIS INCIDENT.

    Description of Event or Problem · 1

    REPORT OF PEDIATRIC HEATED WIRE VENTILATOR CIRCUIT MELTING WHILE IN USE ON A PT IN THE PEDIATRIC ICU. NO NEGATIVE PT RELATED ISSUE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK