MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD NEONATAL NASAL CANNULA OXYGEN THERAPY; CAT

Model Number BC2435

Device Problems Device Issue (2379); Infusion or Flow Problem (2964); No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint bc2435 neonatal oxygen therapy nasal cannula is manufactured by salter labs in (b)(6), for fisher & paykel helathcare ltd.The complaint bc2435 neonatal oxygen therapy nasal cannula is currently en-route to fph in (b)(4) for evaluation, to determine if it had a malfunction which caused or contributed to the reported event.We will provide a follow-up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that a bc2435 neonatal oxygen therapy nasal cannula had no flow.The event was discovered before patient use.

Manufacturer Narrative

(b)(4).The complaint bc2435 neonatal oxygen therapy nasal cannula is manufactured by salter labs in (b)(4), for fisher and paykel healthcare ltd.Method: the complaint bc2435 neonatal oxygen therapy nasal cannula was returned to fph in (b)(4) for evaluation and was visually inspected.Gas was also fed into the cannula connector while the nose piece was submerged in water to determine the presence of bubbles (gas flow).Results: visual inspection revealed an occlusion in the pvc join connector of the subject cannula.No bubbles were observed upon submerging the nose piece in water.Conclusion: there was no gas flow through the subject cannula due to an occlusion, confirming the reported event.The oxygen therapy nasal cannula is approved for use with the rt329 infant continuous flow breathing circuit kit and the mr850 respiratory humidifier.The user instructions that accompany the oxygen therapy nasal cannula state the following: -"patient monitoring is recommended." -"(checks before operation): place hand close to the nasal prongs to ensure that there is airflow exiting the prongs." -"(checks during operation): check that the tubing is not kinked or tangled as this may prevent delivery of oxygen to the patient." there was no patient consequence as the reported event occured before patient use.No other confirmed complaints of this nature have been received for the neonatal oxygen therapy nasal cannula range in the past 12 months (01 may 2016 - 30 april 2017), with (b)(4) units sold.

Event Description

A hospital in (b)(6) reported via a fisher and paykel healthcare (fph) field representative that a bc2435 neonatal oxygen therapy nasal cannula had no flow.The event was discovered before patient use.

• Brand Name: NEONATAL NASAL CANNULA OXYGEN THERAPY
• Type of Device: CAT
• 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: jon stevens ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 6423441
• MDR Text Key: 70519666
• Report Number: 9611451-2017-00230
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC2435
• Device Catalogue Number: BC2435
• Device Lot Number: 150420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2015
• 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