BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR NASAL CANNULA - NEONATAL

    MDR report key: 2970817 · Received February 20, 2013

    Report

    Report Number
    9611451-2013-00103
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 19, 2013
    Report Date
    January 22, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ATTEMPT WAS MADE TO OBTAIN THE COMPLAINT OPT314 OPTIFLOW JUNIOR NASAL CANNULA FOR FURTHER INVESTIGATION BUT THE HOSPITAL DID NOT RETURN IT. WHEN WE FOLLOWED UP WITH THE HOSPITAL, THE DOCTOR WE SPOKE TO ADVISED US THAT SHE DID NOT BELIEVE THE COMPLAINT DEVICE CAUSED THE REPORTED PNEUMOTHORAX. WE WERE FURTHER ADVISED THAT THE HOSPITAL WAS SATISFIED WITH THE PRODUCT AND INTENDED TO CONTINUE ORDERING AND USING IT. WITHOUT FURTHER INFORMATION, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED INCIDENT. FPH HAS NOT RECEIVED COMPLAINTS OF ANY SIMILAR INCIDENTS FOR THIS PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HOSPITAL IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE ALLEGED EVENT AS REPORTED. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE RECEIVED FURTHER INFORMATION AND COMPLETED OUR ANALYSIS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A (B)(6) WAS PUT ON A NEOPUFF RESUSCITATOR (B)(6) DUE TO HYPOXIA AND CYANONIS CONDITIONS. THE INFANT WAS SUBSEQUENTLY PLACED ON AN OPT314 OPTIFLOW JUNIOR NASAL CANNULA WITH A FLOW OF 3LPM OF AIR/OXYGEN MIXTURE (35-40%). THE NASAL CANNULA WAS REPORTEDLY USED IN CONJUNCTION WITH AN MR850 HUMIDIFIER IN AN INVASIVE MODE. THE FOLLOWING DAY, THE INFANT ALLEGEDLY STARTED TO DESATURATE AND X-RAY ALLEGEDLY SHOWED THAT A PNEUMOTHORAX HAD DEVELOPED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A (B)(6) WAS PUT ON A NEOPUFF RESUSCITATOR (B)(6) DUE TO HYPOXIA AND CYANONIS CONDITIONS. THE INFANT WAS SUBSEQUENTLY PLACED ON AN OPT314 OPTIFLOW JUNIOR NASAL CANNULA WITH A FLOW OF 3LPM OF AIR/OXYGEN MIXTURE (35-40%). THE NASAL CANNULA WAS REPORTEDLY USED IN CONJUNCTION WITH AN MR850 HUMIDIFIER IN AN INVASIVE MODE. THE FOLLOWING DAY, THE INFANT ALLEGEDLY STARTED TO DESATURATE AND X-RAY ALLEGEDLY SHOWED THAT A PNEUMOTHORAX HAD DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74866 OPTIFLOW JUNIOR NASAL CANNULA - NEONATAL CAT CAT FISHER & PAYKEL HEALTHCARE LIMITED OPT314 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other