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

Model Number RT132

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt132 infant continuous flow breathing circuit was not returned to fisher & paykel healthcare for evaluation.Our investigation is thus based on the information and photograph provided by the customer and our knowledge of the product.Results: visual inspection of the photograph revealed that the patient end connector disconnected from the inspiratory tube.Conclusion: we are unable to determine what may have caused the reported event.All rt132 infant continuous flow breathing circuits are visually inspected and pressure tested for leaks prior to distribution.Those that fail are discarded.The subject rt132 infant breathing circuit would have met the required specifications 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 fisher & paykel healthcare field representative that the rt132 breathing circuit came apart at the connector.There was no reported patient involvement.

• 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, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 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: 9485472
• MDR Text Key: 181539135
• Report Number: 9611451-2019-01224
• 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: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• 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: 2100747684
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2019
• 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