BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT NASAL MASK

    MDR report key: 5242011 · Received November 22, 2015

    Report

    Report Number
    9611451-2015-00491
    Event Type
    Malfunction
    Date Received
    November 22, 2015
    Date of Event
    September 9, 2015
    Report Date
    October 24, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION AND THE COMPLAINT DEVICES FROM THE HOSPITAL. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO COMPLAINT BC802 INFANT LARGE NASAL MASKS AND TWO COMPLAINT BC803 INFANT EXTRA-LARGE NASAL MASKS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4). THE FOUR RETURNED MASKS WERE VISUALLY INSPECTED. THE DIMENSIONS OF THE FOUR RETURNED MASKS WERE MEASURED AND COMPARED AGAINST THE DRAWING SPECIFICATIONS. THE COMPLAINT BC802 AND BC803 NASAL MASKS HAD ALSO UNDERGONE A DOUBLE LOADING TEST BY FITTING TO A BC192 NASAL TUBING AND ATTACHING ANOTHER SAMPLE OF BC802 NASAL MASK. A GAS FLOW OF 8 LITERS PER MINUTE WAS SUBSEQUENTLY APPLIED TO THE SET-UP FOR SIX HOURS. THE HOSPITAL HAD REPORTED THAT THE MASKS DISCONNECT AFTER ONE OR MORE DAYS WHEN THEY PUSH THE "IN-AND EXPIRATION ON THE SWIVEL". QUESTIONS SEEKING ADDITIONAL INFORMATION REGARDING THIS WERE FORWARDED TO THE CUSTOMER BUT NO REPLY WAS RECEIVED DESPITE FOUR FOLLOW-UP ATTEMPTS. THE FLEXITRUNK USED WITH THE COMPLAINT MASKS WAS NOT RETURNED AND DOES NOT CONTAIN A SWIVEL COMPONENT. THEREFORE OUR INVESTIGATION IS BASED ON OUR KNOWLEDGE OF THE PRODUCT AND PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS CONDUCTED. RESULTS: NO DAMAGE WAS OBSERVED TO THE RETURNED MASKS DURING VISUAL INSPECTION. DIMENSIONS OF ALL RETURNED MASKS WERE WITHIN SPECIFICATIONS. THE MIDLINE CANNULA HOUSING WAS ABLE TO RETAIN TWICE THE MASK'S WEIGHT WITHOUT DETEACHING FROM THE SET-UP. A LOT CHECK FOR LOT NUMBER 140409 (2 DEVICES) AND 150417 (1 DEVICE) REVEALED NO OTHER COMPLAINTS OF THIS NATURE. A LOT CHECK FOR THE FOURTH DEVICE COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED BC802 AND BC803 INFANT NASAL MASKS BASED ON THE INVESTIGATION CONDUCTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE FLEXITRUNK INFANT INTERFACE ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND PROPER USE OF INFANT INTERFACES, INCLUDING THE NASAL MASK AND NASAL TUBING. IT ALSO STATES THE FOLLOWING: - "CONNECT PRONGS AND MASK TO NASAL TUBING ENSURING THAT IT IS INSERTED FULLY." - "IF USING MASK: CONNECT TO PATIENT BY PLACING MASK AROUND THE NOSE. THE MASK SHOULD SIT COMFORTABLY AROUND THE PATIENT'S NOSE. IT MUST NOT OCCLUDE THE NOSTRILS OR TOUCH THE SEPTUM AND SHOULD NOT BE OVER THE LIP OR OVER THE EYES." - "CHECK THAT ALL CIRCUIT CONNECTIONS ARE TIGHT BEFORE USE AND AFTER ANY ADJUSTMENT."

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THEIR BC803 INFANT NASAL MASKS DISCONNECT DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT WHEN THEY "PUSHED THE IN- AND EXPIRATION ON THE SWIVEL" THEIR BC802 AND BC803 INFANT NASAL MASKS DISCONNECT EASILY. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772251 INFANT NASAL MASK BYG BYG FISHER & PAYKEL HEALTHCARE LTD BC803 & BC802 140409 & 150417

    Patients

    Seq Age Sex Outcome Treatment
    1