BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SINGLE-HEATED LIMB CIRCUIT ACCESSORY

    MDR report key: 2052132 · Received March 1, 2011

    Report

    Report Number
    3004365956-2011-00090
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 30, 2011
    Report Date
    February 8, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD - MANUFACTURING PROCESS REVIEW. RESISTANCE MEASUREMENTS OF INSPIRATORY AND EXPIRATORY WIRES. RESULTS - VISUAL EXAMINATION CONFIRMS A MELT IN THE TUBING OF THE CIRCUIT. THE DAMAGE CONSIST OF BOTH COLLAPSED TUBING AND MELTING THROUGH THE HOLES IN THE TUBING. THE MANUFACTURING PROCESS REVIEW OF CATALOG #780-20 WAS REVIEWED AND NO ISSUES WERE DETECTED. THE RESISTANCE OF THE INSPIRATORY AND EXPIRATORY WIRES MEASURED CORRECTLY AT 13.3 OHMS. THIS IS WITHIN THE ALLOWABLE RANGE OF 12.8 TO 14.3 OHMS. THE TYPE OF MELT IS TYPICALLY DUE TO CUSTOMER MISUSE. THE CIRCUIT WAS MOST LIKELY COVERED BY A BLANKET.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CIRCUIT MELTED WHILE IN USE ON A PATIENT. THE NURSE FOUND THE UPPER PART OF THE HIGH FLOW CIRCUIT MELTED AND STUCK TO THE BED LINEN. THE PATIENT'S OXYGEN SATURATION LEVEL DECREASED. THE PATIENT WAS GIVEN OXYGEN VIA BAG AND MASK AND THE PATIENT'S OXYGEN SATURATION INCREASED. IT IS REPORTED THAT THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON SINGLE-HEATED LIMB CIRCUIT ACCESSORY VENTILATOR CIRCUIT BZO TELEFLEX MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HUDSON CONCHA NEPTUNE: CATALOG# 425-00| (MDR# 3003898360-2011-00073)