BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE CPAP GENERATOR

    MDR report key: 6197495 · Received December 22, 2016

    Report

    Report Number
    9611451-2016-00908
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 9, 2016
    Report Date
    December 9, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZD
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BC100 BUBBLE CPAP GENERATOR IS SOLD/DISTRIBUTED AS PART OF THE BC151/BC161/BC171 BUBBLE CPAP DELIVERY SYSTEM IN THE US (510(K) : K100011). METHOD: THE COMPLAINT BC100 BUBBLE CPAP GENERATOR AND PROBE WERE RETURNED TO FPH IN (B)(6) FOR INVESTIGATION. THEY WERE VISUALLY INSPECTED AND THE DIMENSIONS OF THE LID AND PROBE WERE MEASURED. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED BUBBLE CPAP GENERATOR AND PROBE. THE DIMENSION OF THE PROBE WAS WITHIN THE DRAWING SPECIFICATION; HOWEVER, IT WAS OBSERVED THAT THE DIMENSION OF THE LID OF THE COMPLAINT BUBBLE CPAP GENERATOR WAS OUT OF SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 161108. CONCLUSION: BASED ON THE INVESTIGATION CONDUCTED, IT IS LIKELY THAT THE REPORTED FAULT WAS DUE TO THE WIDER DISTANCE BETWEEN THE PROBE CONNECTION ON THE LID. THE HOSPITAL REPORTED THAT NO PATIENT HARM OCCURRED. THE HOSPITAL REPORTED THAT THE EVENT OCCURED AFTER A PERIOD OF USE, WHICH SUGGESTS THAT THE COMPLAINT BUBBLE CPAP GENERATOR HAD THE "PROBE LOOSE" AS REPORTED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. THE EXISTING DESIGN OF THE CPAP PROBE IS INTENDED TO BE ADJUSTABLE, WHICH LEADS TO THE POSSIBILITY OF INADVERTENT MOVEMENT. THIS RISK HAS BEEN CONSIDERED IN OUR HAZARD ANALYSIS AND DEEMED TO BE ACCEPTABLE DUE TO THE PROVISION OF A PHYSICAL STOP IN THE BUBBLE CPAP PROBE, TO PREVENT THE PRESSURE FROM EXCEEDING 10 CM H20, AND THE USE OF A PRESSURE MANIFOLD WITH THE BREATHING CIRCUIT, TO REDUCE THE RISK OF UNSAFE CIRCUIT PRESSURE. THE BUBBLE CPAP SYSTEM IS FOR USE IN THE HOSPITAL CLINIC ENVIRONMENT SUCH AS THE NEONATAL INTENSIVE CARE UNIT (NICU) AND PAEDIATRIC INTENSIVE CARE UNIT (PICU). THE USER INSTRUCTIONS THAT ACCOMPANY THE BUBBLE CPAP SYSTEM KIT ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND PROPER USE OF THE BUBBLE CPAP GENERATOR. IT ALSO STATES THE FOLLOWING: - "ALWAYS USE PRESSURE MONITORING TO VERIFY THAT THE PATIENT IS RECEIVING THE PRESCRIBED CPAP LEVEL." - "REGULARLY OBSERVE THE CPAP GENERATOR FOR BUBBLING. IF BUBBLING IS NOT OBSERVED, CHECK FOR AND MINIMIZE THE AIR LEAKS IN THE SYSTEM AND AT THE PATIENT. IF AIR LEAKS HAVE BEEN MINIMIZED, AIR FLOW MAY BE INCREASED TO ACHIEVE CONTINUOUS BUBBLING."

    Additional Manufacturer Narrative · 1

    (B)(4). THE 950N60 IS NOT CURRENTLY SOLD IN THE USA HOWEVER IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K100011. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT DEVICE FROM THE HOSPITAL FOR EVALUATION, TO DETERMINE IF IT HAD A MALFUNCTION WHICH MIGHT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE WILL SUBMIT A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE PROBE OF THE BC100 BUBBLE CPAP GENERATOR WAS LOOSE. IT WAS REPORTED THAT THE PROBE HAD DROPPED, INCREASING THE PRESSURE FROM 8 CM H2O TO 10 CM H2O. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE PROBE OF A 950N60 NEONATAL BUBBLE CPAP KIT WAS LOOSE. IT WAS REPORTED THAT THE PROBE HAD DROPPED, INCREASING THE PRESSURE FROM 8CMH2O TO 10CMH2O. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847857 BUBBLE CPAP GENERATOR BZD BZD FISHER & PAYKEL HEALTHCARE LTD BC100 161108

    Patients

    Seq Age Sex Outcome Treatment
    1