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

Model Number RT226

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2024

Event Type  malfunction  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 336187960
• Report Number: 9611451-2024-00089
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012431165
• UDI-Public: (01)09420012431165(10)2102688478(11)230711
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1