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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INFANT CONTINUOUS FLOW BREATHING CIRCUIT; BTT
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INFANT CONTINUOUS FLOW BREATHING CIRCUIT; BTT Back to Search Results
Model Number RT324
Device Problems Disconnection (1171); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 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.
 
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 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.
 
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Brand Name
INFANT CONTINUOUS FLOW BREATHING CIRCUIT
Type of Device
BTT
MDR Report Key11270471
MDR Text Key231338435
Report Number9611451-2021-00131
Device Sequence Number1
Product Code BTT
UDI-Device Identifier09420012431127
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
PMA/PMN Number
K020332
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRT324
Device Catalogue NumberRT324
Device Lot NumberSEE H10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2021
Date Manufacturer Received05/05/2021
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 Number1
Treatment
VIASYS SIPAP VENTILATOR; VIASYS SIPAP VENTILATOR
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