MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED ADULT DUAL HEATED BREATHING CIRCUIT; BTT

Model Number RT200

Device Problem Gas/Air Leak (2946)

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

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The rt200 is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.Method: the complaint rt200 adult dual-heated breathing circuit was not returned to fisher & paykel healthcare for evaluation.Our investigation is thus based on the information and photograph provided by the customer, and our knowledge of the product.Results: visual inspection on the provided photograph revealed that the grommet of the rt200 adult dual-heated breathing circuit was incorrectly assembled in the inspiratory elbow.Conclusion: we are unable to determine the cause of the reported event, however the grommet was likely incorrectly assembled during production.All rt200 adult dual heated breathing circuits are visually inspected, and pressure and flow tested during production, and those that fail are rejected.The user instructions that accompany the rt200 adult dual heated breathing circuit state: ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Check all connections are tight before use.

Event Description

A distributor reported on behalf of a healthcare facility in (b)(4) that the grommet of a rt200 adult breathing circuit was "out of position".There was no patient involvement.

• Brand Name: ADULT DUAL HEATED BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 12627280
• MDR Text Key: 276909212
• Report Number: 9611451-2021-01131
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012430328
• UDI-Public: (01)09420012430328(10)2101520440(11)210221
• 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: distributor,foreign,health pr
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT200
• Device Catalogue Number: RT200
• Device Lot Number: 2101520440
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2021
• 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