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

Model Number RT228

Device Problem Component Missing (2306)

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

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt228 infant breathing circuit is not sold in the usa but is similar to a product that is sold in the usa.The 510(k) for the similar product is k020332.Method: the complaint rt228 infant breathing circuit was returned to fisher & paykel healthcare (f&p) in (b)(6) for evaluation, where it was visually inspected by a trained f&p technician.Results: the pressure line port cap was returned with the complaint rt228 circuit.The pressure line port cap was able to be reattached to the pressure line port.Conclusion: we are unable to determine the cause of the reported event.The user instructions that accompany the rt228 infant breathing circuit state the following: check all connections are tight before use.Ensure appropriate venitlator or flow source alarms are set before connecting breathing set to patient.Appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in serious harm or death.

Event Description

A distributor in (b)(4) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that a rt228 infant breathing circuit did not have a pressure cap on the pressure line connection of the expiratory circuit.There was no patient involvement.

• Brand Name: INFANT BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 10989658
• MDR Text Key: 220905125
• Report Number: 9611451-2020-01136
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012431172
• UDI-Public: 010942001243117210210070530511190
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial
• Report Date: 11/13/2020

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: RT228
• Device Catalogue Number: RT228
• Device Lot Number: 2100705305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2019
• 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