MAUDE Adverse Event Report: INFANT CONTINUOUS FLOW BREATHING CIRCUIT; BTT

Model Number	RT324
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Lot # and device manufacture date: device 1: lot 2100982333, dom 15 jan 2020.Device 2: lot 2101168943, dom 23 jun 2020.Device 3: lot 2101169522, dom 23 jun 2020.The three complaintrt 324 infant continuous flow breathing circuits are currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in ireland reported via a fisher & paykel healthcare (f&p) field representative that the pressure line component of three rt324 infant continuous flow breathing circuits was not connecting properly to a viasys ventilator.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).D4 lot # and h4 device manufacture date device 1: lot 2100982333, dom 15 jan 2020 device 2: lot 2101168943, dom 23 jun 2020 device 3: lot 2101169522, dom 23 jun 2020 method: the complaint rt324 infant continuous flow breathing circuits were returned to fph in new zealand for inspection, where it was visually inspected.Results: no fault was found with the returned pressure lines and breathing circuits.Conclusion: we are unable to determine the cause of the reported fault as no fault was found to the returned breathing circuits.All infant breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails any of these tests is discarded.Our user instructions which accompany the rt324 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 alarm.
Event or Problem Description
A healthcare facility in ireland reported via a fisher & paykel healthcare (f&p) field representative that the pressure line component of three rt324 infant continuous flow breathing circuits was not connecting properly to a viasys ventilator.There was no reported patient consequence.

• Brand Name: INFANT CONTINUOUS FLOW BREATHING CIRCUIT
• Common Device Name: BTT
• MDR Report Key: 11270471
• Report Number: 9611451-2021-00131
• Device Sequence Number: 19767327
• Product Code: BTT
• UDI-Device Identifier: 09420012431127
• UDI-Public: (01)09420012431127(10)2100982333(11)200115,(01)09420012431127(10)2101168943(11)200623,(01)09420012431127(10)2101169522(11)200623
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K020332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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
• Operator of Device: Health Professional
• Device Model Number: RT324
• Device Catalogue Number: RT324
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 06/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VIASYS SIPAP VENTILATOR; VIASYS SIPAP VENTILATOR