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

Model Number BC151-10

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: one complaint bubble cpap generator and probe were returned to fisher & paykel healthcare in (b)(6) for investigation.The complaint components were visually inspected and the dimensions of the probe and the lid of the bubble cpap generator were measured.Results: visual inspection revealed that there was no damage to the bubble cpap generator and probe.Measurement of the probe and lid revealed that the dimensions of the probe were within specification.The probe connection on the lid was out of specification, as the diameter was too large.Conclusion: it is likely that the probe moved from its set position due to the wider diameter of the probe connection on the lid.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 hospital/clinical environments, 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 that the probes of three bc151-10 bubble cpap system kits had slid from their set positions and dropped lower into the bubble cpap generators, increasing the air pressure.No patient consequence was reported.

• Brand Name: BUBBLE CPAP SYSTEM
• Type of Device: BTT
• 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; 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology drive; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6844210
• MDR Text Key: 85127981
• Report Number: 9611451-2017-00830
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2017

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: BC151-10
• Device Catalogue Number: BC151-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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