MAUDE Adverse Event Report: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT266

Device Problems Material Puncture/Hole (1504); Material Perforation (2205)

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

Event Date 11/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of retrieving further information regarding the complaint rt266 infant dual-heated evaqua2 breathing circuit.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in florida reported that a rt266 infant dual-heated evaqua2 breathing circuit had a pin hole on the inspiratory tube.There was no patient consequences.

Manufacturer Narrative

Ps374916, method: the complaint rt266 infant dual-heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer revealed that a rt266 infant dual-heated evaqua2 breathing circuit had a pin hole on the inspiratory tube.Conclusion: without the complaint device, we are unable to determine what may have caused the reported event.All rt266 infant dual-heated evaqua2 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 rt266 infant dual-heated evaqua2 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 alarms.".

Event Description

A healthcare facility in florida reported that a rt266 infant dual-heated evaqua2 breathing circuit had a pin hole on the inspiratory tube.There was no patient consequences.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 12305449
• MDR Text Key: 267524196
• Report Number: 9611451-2021-00936
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 09420012431103
• UDI-Public: (01)09420012431103(10)2101225886(11)200807
• Combination Product (y/n): N
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT266
• Device Catalogue Number: RT266
• Device Lot Number: 2101225886
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2020
• 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