BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE CPAP SYSTEM

    MDR report key: 6239847 · Received January 10, 2017

    Report

    Report Number
    9611451-2017-00004
    Event Type
    Malfunction
    Date Received
    January 10, 2017
    Report Date
    December 12, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZD
    PMA / PMN Number
    K100011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT BC151 BUBBLE CPAP SYSTEM KIT AND PROBE WAS RETURNED TO FPH IN (B)(4) AND WAS VISUALLY INSPECTED. THE DIMENSIONS OF THE LID AND THE PROBE OF THE BUBBLE CPAP SYSTEM WERE MEASURED. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED BUBBLE CPAP GENERATOR. 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 OUTSIDE SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 160707. CONCLUSION: BASED ON THE INVESTIGATION CONDUCTED, IT IS LIKELY THAT THE REPORTED FAULT WAS DUE TO THE WIDER DISTANCE BETWEEN THE PROBE CONNECTION OF THE BUBBLE CPAP GENERATOR LID. NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT. 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."

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT BC151 BUBBLE CPAP SYSTEM KIT AND PROBE IS CURRENTLY EN-ROUTE TO FPH IN (B)(4) FOR INVESTIGATION, TO DETERMINE IF IT HAD A MALFUNCTION WHICH MIGHT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE WILL PROVIDE 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 (FPH) REPRESENTATIVE THAT THE BUBBLE CPAP PROBE OF A BC151 BUBBLE CPAP SYSTEM KIT WAS LOOSE AND SLIPPED FROM THE SET POSITION TWICE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THE BUBBLE CPAP PROBE OF A BC151 BUBBLE CPAP SYSTEM KIT WAS LOOSE AND SLIPPED FROM THE SET POSITION TWICE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21491 BUBBLE CPAP SYSTEM BZD BZD FISHER & PAYKEL HEALTHCARE LTD BC151-10 2100061956

    Patients

    Seq Age Sex Outcome Treatment
    1