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

Model Number RT132

Device Problem Disconnection (1171)

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

Event Date 07/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt132 infant continuous flow breathing circuit is en route to fisher & paykel healthcare in (b)(4) for investigation.We will provide a follow-up report once we have completed our investigation.

Event Description

A healthcare facility in (b)(6) reported via a distributor that the pressure line of an rt132 infant continuous flow breathing circuit came off easily when connected to the breathing circuit and the interface during set up.

Manufacturer Narrative

(b)(4).Method: the inspiratory limb, pressure line and dryline of the complaint rt132 infant continuous flow breathing circuit was returned to fisher & paykel healthcare in (b)(4) and were visually inspected.Results: no physical damage was observed to any of the returned components.A lot check was not performed as lot information was not provided.Conclusion: we were unable to confirm the fault reported by the customer as the pressure line connects directly to the ventilator and generator at the healthcare facility.All infant breathing circuits are visually inspected and pressure tested before leaving the production line, and those that fail are rejected.The pressure line of the subject rt132 adult breathing circuit would have met the required specification at the time of production.The user instructions that accompany the rt132 infant continuous flow breathing circuit state the following: "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 healthcare facility in (b)(6) reported via a distributor that the pressure line of an rt132 infant continuous flow breathing circuit came off easily when connected to the breathing circuit and the interface during set up.

• Brand Name: INFANT CONTINUOUS FLOW BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine; 9494534000
• MDR Report Key: 5041459
• MDR Text Key: 25629570
• Report Number: 9611451-2015-00385
• 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: distributor,foreign,user faci
• Reporter Occupation: Other
• Report Date: 08/04/2015

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: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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