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

Model Number RT200

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher and paykel healthcare representative that the y piece of five rt200 adult breathing circuits kept disconnecting from the inspiratory and expiratory limbs very easily.No patient consequences were reported.

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.The complaint rt200 breathing circuits were not returned to fisher & paykel healthcare (fph) (b)(4) for inspection.Our investigation is therefore based on the information provided and our knowledge of the product.Following the reported incident, an fph field representative visited the hospital to discuss the correct fitting and set-up of the rt200.During the discussion it became evident that the reported incident was due to user error not a faulty product.Our field representative has arranged further training for ward staff regarding this.The user instructions that accompany the rt200 breathing circuit state: check all connections are tight before use.Set appropriate ventilator alarms.

• Brand Name: ADULT DUAL HEATED 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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 3936744
• MDR Text Key: 18867893
• Report Number: 9611451-2014-00615
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2014

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: RT200
• Device Catalogue Number: RT200
• Device Lot Number: 1310300301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2014
• Initial Date FDA Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2013
• 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