BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 292205 · Received August 11, 2000

    Report

    Report Number
    9611451-2000-00003
    Event Type
    Other
    Date Received
    August 11, 2000
    Date of Event
    June 23, 2000
    Report Date
    August 11, 2000
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEATER WIRE OF THE DUAL HEATED ALLEGIANCE BREATHING CIRCUIT (#7100-4S2) HAD MELTED THROUGH THE WALL OF THE INSPIRATORY LIMB. A SINGLE LIMB ALLEGIANCE ELECTRICAL ADAPTOR (#0060-20) HAD BEEN USED WITH THE CIRCUIT. THIS LED TO THE INSPIRATORY HEATER WIRE OVERHEATING. THERE WERE NO INJURIES TO THE NEONATAL PT. INSERVICE TRAINING OF THE STAFF AS TO THE PROPER SET-UP OF THE EQUIPMENT HAS BEEN AGREED TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * HEATED RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD MR730JHY *

    Patients

    Seq Age Sex Outcome Treatment
    1 *