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

Model Number RT132

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt132 infant continuous flow breathing circuit is currently en route to fisher & paykel healthcare in (b)(4) for evaluation.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in the (b)(6) reported via a fisher & paykel healthcare field representative that the pressure line component of an rt132 infant continuous breathing circuit became disconnected easily before use on a patient.There was no patient involvement.

Manufacturer Narrative

Ps308862 method: the complaint device rt132 infant continuous flow breathing circuit was not retruned.A device from the same batch was returned to fph in new zealand for evaluation.The returned breathing circuit had an intact package seal and was visually inspected and tested.Results: the fault was not replicated with the returned sample, as the pressure line connects directly to the ventilator and generator.Conclusion: based on the investigation conducted, we were unable to determine what may have caused the failure as reported by the customer, as no fault was found with the returned device.All breathing circuits are pressure tested and visually inspected prior to being released for distribution, and those that fail are rejected.The user instructions that accompany the rt132 infant continuous flow breathing circuit states: -"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 the united kingdom reported via a fisher & paykel healthcare field representative that the pressure line component of an rt132 infant continuous breathing circuit became disconnected easily before use on a patient.There was no 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
• MDR Report Key: 8642516
• MDR Text Key: 146248738
• Report Number: 9611451-2019-00526
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

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: 2100464070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1