MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT INSPIRATORY HEATED BREATHING CIRCUIT; BTT

Model Number RT114

Device Problem Torn Material (3024)

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

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt114 adult inspiratory heated breathing circuits were not available to be returned to fisher & paykel healthcare in (b)(4) for investigation.Results: without the return of the complaint devices, we were unable to determine what may have caused the reported issue.All rt114 adult inspiratory heated breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The user reported that the damage was observed during use, which suggests that the complaint breathing circuit became damaged after it was released for distribution.The user instructions that accompany the rt114 adult inspiratory-heated breathing circuit state the following: - "do not stretch or milk the tubing." - "set appropriate ventilator alarms.".

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (f&p) field representative that a rt114 adult inspiratory heated breathing circuit tore during the first night of use.It was reported that a second circuit was placed on the patient and the patient allegedly woke with a decreased o2 level.It was further reported that "it is possible that the tubing was accidentally pulled".No patient consequence was reported.

• Brand Name: ADULT INSPIRATORY HEATED 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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7524299
• MDR Text Key: 108731776
• Report Number: 9611451-2018-00417
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT114
• Device Catalogue Number: RT114
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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