BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE CPAP SYSTEM

    MDR report key: 2370968 · Received December 13, 2011

    Report

    Report Number
    9611451-2011-00778
    Event Type
    Malfunction
    Date Received
    December 13, 2011
    Date of Event
    November 13, 2011
    Report Date
    November 14, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BC161 BUBBLE CPAP SYSTEM KIT IS NOT SOLD IN THE USA BUT THE BREATHING CIRCUIT INCLUDED IN THE KIT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. THE BC161-10 BUBBLE CPAP SYSTEM IS DESIGNED FOR USE WITH SPONTANEOUSLY BREATHING INFANTS WHO REQUIRE CPAP THERAPY. WE HAVE SUBSEQUENTLY BEEN INFORMED THAT THE HOSPITAL HAD DISCARDED THE COMPLAINT DEVICES. FURTHER INFORMATION WAS SOUGHT REGARDING THE REPORTED LEAKS, SUCH AS WHETHER THERE WAS ANY OBVIOUS PHYSICAL DAMAGE NOTED TO THE PRESSURE MANIFOLD AND DETAILS ABOUT GAS FLOW AND PRESSURE, BUT NO DETAILS WERE PROVIDED. WE HAD ALSO ENDEAVOURED TO OBTAIN OTHER SAMPLE DEVICES FROM THE SAME BATCH BUT HAVE NOT BEEN SUCCESSFUL IN THIS REGARD. WITHOUT ADDITIONAL INFORMATION OR THE RETURN OF THE COMPLAINT DEVICES, FISHER & PAYKEL HEALTHCARE WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAULT. THE BUBBLE CPAP USER INSTRUCTIONS INCLUDE THE FOLLOWING STATEMENTS: CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE AND AFTER ANY ADJUSTMENT REGULARLY OBSERVE THE WATER LEVEL IN THE CPAP GENERATOR AND OVERFLOW CONTAINER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE BC161 BUBBLE CPAP SYSTEM KIT IS NOT SOLD IN THE USA BUT THE BREATHING CIRCUIT INCLUDED IN THE KIT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. WE ARE CURRENTLY ENDEAVOURING TO RETRIEVE THE COMPLAINT DEVICES AND OBTAIN FURTHER INFORMATION ABOUT THIS COMPLAINT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO BC161-10 BREATHING CIRCUITS WERE LEAKING FROM THE PRESSURE MANIFOLD. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO BC161-10 BREATHING CIRCUITS WERE LEAKING FROM THE PRESSURE MANIFOLD. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUBBLE CPAP SYSTEM BTT BTT FISHER & PAYKEL HEALTHCARE LTD BC161-10 110613

    Patients

    Seq Age Sex Outcome Treatment
    1