MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT; BTT

Model Number RT319

Device Problem Hole In Material (1293)

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

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt319 adult breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is (b)(4).The complaint rt319 adult breathing circuit is currently en route to fph in (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(4) reported via a fisher & paykel healthcare (fph) field representative that the rt319 adult breathing circuit had a hole.This was found after five days of use.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The rt319 adult breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.Method: the complaint rt319 adult breathing circuit was returned to fph in (b)(6) for evaluation where it was visually inspected.Results: visual inspection revealed that the tubing had a hole that was 67 cm from the patient end connector.The puncture appears to have been made with a sharp object.Conclusion: we are unable to determine what may have caused the event reported by the customer.We note that the customer reported that the hole was found after five days of use.All breathing circuits are visually inspected before leaving the production line.The user instructions accompanied by the rt319 adult breathing circuit state: before connecting to patient, ensure that flow and pressure testing applicable to the ventilator has been completed.Set appropriate ventilator alarms.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that the rt319 adult breathing circuit had a hole.This was found after five days of use.No patient consequence was reported.

• Brand Name: BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 7180541
• MDR Text Key: 97491197
• Report Number: 9611451-2018-00019
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

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: RT319
• Device Catalogue Number: RT319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 12/13/2017
• Supplement Dates FDA Received: 02/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1