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

Model Number RT132

Device Problem Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) method: the complaint rt132 infant continous flow breathing circuit was returned to fisher & paykel healthcare in (b)(4) where it was visually inspected for the reported damage.Results: visual inspection revealed that the patient end cuff of the inspiratory limb was split.A lot check revealed no other complaints of this nature for lot 150507.Conclusion: we are unable to determine the cause of the damage observed on the returned inspiratory limb.The inspiratory limb may have been damaged when the circuit or box was opened by the user.All infant breathing circuits are pressure tested, flow tested and visually inspected for damage prior to being released for distribution.The user instructions that accompany the rt132 infant continous flow breathing circuit state the following: "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)(4) reported via a fisher & paykel healthcare representative that an rt132 infant continous flow breathing circuit had a torn cuff.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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9194534000
• MDR Report Key: 5405537
• MDR Text Key: 37735601
• Report Number: 9611451-2016-00030
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• 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: 150507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2015
• 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