BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMEDIATE INFANT OXYGEN THERAPY NASAL CANNULA

    MDR report key: 2216920 · Received August 19, 2011

    Report

    Report Number
    9611451-2011-00503
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    July 24, 2011
    Report Date
    July 29, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT BC2755 NASAL CANNULAS ARE NOT EXPECTED TO BE RETURNED TO FPH (B)(4) FOR INSPECTION AS THEY HAVE BEEN DESTROYED AT THE HOSPITAL. OUR ANALYSIS IS BASED ON THE EVENT DESCRIPTION AND PHOTOGRAPHS PROVIDED BY THE HOSPITAL. A VISUAL INSPECTION OF THE PHOTOGRAPHS OF THE COMPLAINT DEVICES REVEALED THAT THE CANNULA TUBE WAS DETACHED FROM THE NOSE PIECE OF THE BC2755. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 091024. (B)(4). WITHOUT THE COMPLAINT DEVICES WE ARE UNABLE TO DETERMINE IF THE TUBE WAS PROPERLY (B)(4) OR IF THERE WAS ANY DAMAGE TO THE SURFACE OF THE TUBING. NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THE FOLLOWING TO A FISHER & PAYKEL HEALTHCARE (FPH) TERRITORY MANAGER INVOLVING A BC2755 INTERMEDIATE INFANT OXYGEN THERAPY NASAL CANNULA: A (B)(6) INFANT WAS ON AN (B)(4) RESPIRATORY HUMIDIFIER AND A BC2755 INTERMEDIATE INFANT OXYGEN THERAPY NASAL CANNULA WHEN THE SATURATION STARTED DROPPING FROM 100% TO 90%. THE PARENT OF THE INFANT NOTICED THAT THE TUBE OF A BC2755 HAD BECOME DETACHED FROM ONE SIDE OF THE NASAL PRONGS. THE TUBE WAS REPLACED, HOWEVER, IT ALSO BECAME DETACHED SHORTLY AFTER SET UP. THE FLOW RATE WAS 7 L/MIN, AS PER THE RECOMMENDED MAXIMUM FLOW RATE SPECIFIED IN THE USER INSTRUCTIONS OF THE BC2755 NASAL CANNULA. NO PATIENT CONSEQUENCE WAS REPORTED. THE LOT NUMBER OF THE FIRST BC2755 DEVICE USED WAS NOT CONFIRMED AS THE ORIGINAL PACKAGING WAS DESTROYED. THE LOT NUMBER OF THE REPLACEMENT NASAL CANNULA WAS 091024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMEDIATE INFANT OXYGEN THERAPY NASAL CANNULA CAT CAT FISHER & PAYKEL HEALTHCARE LIMITED BC2755 091024

    Patients

    Seq Age Sex Outcome Treatment
    1