BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE CPAP GENERATOR

    MDR report key: 6338161 · Received February 16, 2017

    Report

    Report Number
    9611451-2017-00104
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    December 21, 2016
    Report Date
    January 18, 2017
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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 WAS DESTROYED AT THE HOSPITAL. THEREFORE, OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, PREVIOUS SIMILAR INVESTIGATIONS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: WITHOUT THE RETURN OF THE COMPLAINT DEVICE, WE WERE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM REPORTED BY THE HOSPITAL. CONCLUSION: 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 10CMH20 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A NURSE HAD SET THE PROBE OF A BC100 BUBBLE CPAP GENERATOR AT 8 OR 9 CMH2O AND CAME BACK TO FIND IT AT 10 CMH2O. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119201 BUBBLE CPAP GENERATOR BZD BZD FISHER & PAYKEL HEALTHCARE LIMITED BC100 161109

    Patients

    Seq Age Sex Outcome Treatment
    1