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

Model Number	RT226
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a healthcare facility, via a fisher & paykel (f&p) healthcare representative in japan that the water trap of a rt226 infant ventilator breathing circuit was observed to be cracked when being removed from the packacking.There was no patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The subject rt226 infant ventilator breathing circuit has been requested to be returned to f&p healthcare new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(4).Method: the subject rt226 infant ventilator breathing circuit was returned to f&p healthcare in new zealand where it was visually inspected and analysed.Results: visual inspection of the returned rt226 infant ventilator breathing circuit confirmed a long vertical crack on the outside of the water trap.The inside wall of the water trap was observed cracked in multiple directions.Material analysis confirmed that there was no evidence of material degradation and the most likely cause of the crack is an external mechanical impact.Conclusion: we are unable to determine the cause of the reported crack.However, based on the conducted analysis, the crack is likely to have occurred due to an external impact.All rt226 infant low flow breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.The user instructions that accompany the rt226 infant low 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." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".
Event or Problem Description
A distributor reported on behalf of a healthcare facility, via a fisher & paykel (f&p) healthcare representative in japan that the water trap of a rt226 infant ventilator breathing circuit was observed to be cracked when being removed from the packaging.There was no patient involvement reported.

• Brand Name: INFANT VENTILATOR 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 18673617
• Report Number: 9611451-2024-00089
• Device Sequence Number: 15258199
• Product Code: BTT
• UDI-Device Identifier: 09420012431165
• UDI-Public: (01)09420012431165(10)2102688478(11)230711
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: RT226
• Device Catalogue Number: RT226
• Device Lot Number: 2102688478
• 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: 01/12/2024
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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