MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD BUBBLE CPAP SYSTEM; BZD

Model Number BC161-10

Device Problem Leak/Splash (1354)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Event Description

A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that the bc161-10 bubble cpap system was leaking and not bubbling.It was further reported by the healthcare facility that the patient desaturated to 60%.They were removed from the bc161-10 bubble cpap system, a bag-valve-mask (bvm) was applied by a registered nurse (rn) and they began bagging with 100% o2 for approximately 5-10 minutes until saturation improved to 100% the healthcare facility examined the tubing and there was a small port (pressure monitoring port) that was open, causing a leak.The healthcare facility then attempted to re-apply the bc161-10 bubble cpap system but due to the patient opening their mouth and ongoing crying from the mouth, the bc161-10 bubble cpap system did not seal and was not functional.When one of the nicu nurses quickly shut babies mouth you could see the odd bubble in the water chamber but then once they let go of babies mouth there was no bubbling.

Manufacturer Narrative

(b)(4).Method: the bc161-10 bubble cpap system was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photography provided by the customer and our knowledge of our product.Results: the customer reported that the bc161-10 bubble cpap system was leaking and not bubbling.Based on provided information, the leak could happen due to the baby crying because the customer observed bubbling when the baby's mouth was covered and no bubbling as they let go of the mouth.The photo provided only shows the example of the port (pressure monitoring port) on the flexitrunk which was reported to have been left open during therapy.No observation can be made based on the photo.Conclusion: without the complaint device, we are unable to determine the cause of the reported fault.The following warnings are present in the bc151/bc161 user instruction: ensure audible continuous bubbling is maintained.Always use pressure monitoring to verify that the patient is receiving the prescribed cpap level.

• Brand Name: BUBBLE CPAP SYSTEM
• Type of Device: BZD
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17726722
• MDR Text Key: 323158824
• Report Number: 9611451-2023-00854
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K100011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BC161-10
• Device Catalogue Number: BC161-10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: F&P AIRVO POLE STAND; F&P BC191 FLEXITRUNK; F&P MR850 RESPIRATORY HUMIDIFIER; HS10IA-DHDCF4 BLACK AIR HOSE 10' DISS-DISS; HS10IO-DHDCC4 WHITE O2 HOSE 10' DISS; R229P01-001 MAXBLEND LOW FLOW BLENDER
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 37 WK