BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE CPAP CIRCUIT

    MDR report key: 2148925 · Received July 5, 2011

    Report

    Report Number
    9611451-2011-00405
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 10, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), PMA/510(K): THE (B)(4) BUBBLE CPAP CIRCUIT IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. MANUFACTURER NARRATIVE: THE BC161 BUBBLE CPAP CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE, AND HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE BC161 BUBBLE CPAP CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K020332. MANUFACTURER NARRATIVE THE COMPLAINT BC161 BUBBLE CPAP CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAULT. ALL BREATHING CIRCUITS ARE TESTED FOR CONNECTIVITY AND ELECTRICAL CONTINUITY DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE CIRCUITS ARE ALSO REJECTED IF THEY ARE UNABLE TO FIT INTO THE TESTING DEVICE. IT IS THEREFORE MOST LIKELY THAT THE PIN OF THE COMPLAINT BC161 CIRCUIT WAS DAMAGED POST PRODUCTION, POSSIBLY DURING THE SET-UP AND CONNECTION OF THE EQUIPMENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE HEATER WIRE PINS OF A NEWLY OPENED BC161 BUBBLE CPAP CIRCUIT KIT WERE BROKEN. THIS WAS NOTICED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE HEATER WIRE PINS OF A NEWLY OPENED BC161 BUBBLE CPAP CIRCUIT KIT WERE BROKEN. THIS WAS NOTICED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUBBLE CPAP CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED BC161 101203

    Patients

    Seq Age Sex Outcome Treatment
    1