MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT CONTINUOUS FLOW BREATHING CIRCUIT; BTT

Model Number RT132

Device Problem Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt132 infant continuous flow breathing circuit was returned to fph in (b)(4) for evaluation.The returned breathing circuit was visually inspected.Results: visual inspection revealed that the pressure line was damaged.Conclusion: based on the investigation conducted, the tube was likely overstretched during adaptor assembly.Production operators are instructed to discard any pressure lines that become damaged during the stretching process in the standard operating procedure.In addition, all breathing circuits are pressure tested and visually inspected prior to being released for distribution, and those that fail are rejected.The user instructions that accompany the rt132 infant continuous flow breathing circuit states: -"check all connections are tight before use." -"perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." -"set appropriate ventilator alarms.".

Event Description

A distributor in (b)(6) reported that the pressure line of one rt132 infant breathing circuit had a hole.Investigation of the returned device (on 22 june 2017) confirmed the reported event: the pressure line was damaged.This was found before use on a patient.

• Brand Name: INFANT CONTINUOUS FLOW BREATHING CIRCUIT
• 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; auckland, 2013 ; NZ 2013
• Manufacturer Contact: irfanali kermalli ; 173 technology dr. suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6662664
• MDR Text Key: 78256027
• Report Number: 9611451-2017-00584
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2017

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: RT132
• Device Catalogue Number: RT132
• Device Lot Number: 2100006207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2015
• 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