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

Model Number BC100

Device Problem Device Issue (2379)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

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.

Manufacturer Narrative

(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.".

Event Description

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.

• Brand Name: BUBBLE CPAP GENERATOR
• 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: raymond yan ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6197495
• MDR Text Key: 63080578
• Report Number: 9611451-2016-00908
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC100
• Device Catalogue Number: BC100
• Device Lot Number: 161108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• 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