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

Model Number	RT132
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint rt132 infant continuous flow breathing circuit is 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 distributor in (b)(4) reported on behalf of a distributor in (b)(4) that the pressure line of an rt132 infant continuous breathing circuit would not connect to the ventilator.There was no patient involvment.
Additional Manufacturer Narrative
(b)(4).Correction: h6 health effect - impact code incorrectly selected - changed to 2645.As the event occurred before patient use, there is no patient involvement.Method: the complaint rt132 infant continuous flow breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation, where it was visually inspected and performance tested.Results: visual inspection of the rt132 infant continuous flow breathing circuit did not identify any damage or moulding defects.Performance testing of the returned circuit revealed the pressure line connected directly to the ventilator and generator as intended.Conclusion: we are unable to determine the cause of the reported event as no fault was found with the returned rt132 infant continuous flow breathing circuit.All rt132 infant continuous flow breathing circuits are visually inspected and pressure tested prior to being released for distribution, and those that fail are rejected.The subject rt132 infant continuous flow 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 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." ensure approptiate ventilator or flow source alarms are set before connecting breathing set to patient." "failure to comply with any of the following warnings may impair performance of the device or compromise safety (including potentially causing serious harm).".
Event or Problem Description
A distributor in italy reported on behalf of a distributor in france that the pressure line of an rt132 infant continuous flow breathing circuit would not connect to the ventilator.There was no patient involvement.

• Brand Name: INFANT CONTINUOUS FLOW BREATHING CIRCUIT
• Common Device Name: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14018107
• Report Number: 9611451-2022-00344
• Device Sequence Number: 5300673
• Product Code: BTT
• UDI-Device Identifier: 09420012431110
• UDI-Public: (01)09420012431110(10)2101190254(11)200707
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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: RT132
• Device Catalogue Number: RT132
• Device Lot Number: 2101190254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2020
• 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
• Patient Sex: Unknown