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

Model Number RT126

Device Problem Gas/Air Leak (2946)

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

Event Date 08/25/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt126 infant low 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 investigation.

Event Description

A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative, that a rt126 infant low flow breathing circuit failed the ventilator leak test before use.There was no patient involvement.

Event Description

A distributor reported on behalf of a healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative, that a rt126 infant low flow breathing circuit failed the ventilator leak test before use.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint rt126 infant low flow breathing circuit was returned to fisher & paykel healthcare (f&p) in new zealand, where it was visually inspected and leakage tested.Results: visual inspection of the returned rt126 infant low flow breathing circuit revealed no damage to the returned breathing circuit or the dryline.The leakage test also revealed that the breathing circuit was within specification.Conclusion: we were unable to determine what may have caused the leakage as reported by the customer, as no fault was found with the returned device.All rt126 infant low flow breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The subject infant breathing circuit would have met the required specifications at the time of production.Our user instructions that accompany the rt126 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.".

• Brand Name: INFANT LOW FLOW 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 15343205
• MDR Text Key: 299180934
• Report Number: 9611451-2022-00813
• Device Sequence Number: 1
• Product Code: BTT
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT126
• Device Catalogue Number: RT126
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2022
• 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 Number: 1