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

Model Number RT210

Device Problems Insufficient Heating (1287); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via our distributor that the rt210 adult breathing circuits would not heat up and that changing the breathing circuit for another solved the problem.No patient consequence was reported.

Manufacturer Narrative

(b)(4).The complaint rt210 breathing circuits were returned to fisher & paykel healthcare (b)(4)for inspection.The hospital informed us that the circuits had been thrown out for infection prevention reasons.Our investigation is based on the information provided by the hospital and our knowledge of the product.Based on the information provided, it appears likely that there was an open circuit in the heater wire, most likely as a result of poor connection between the heater wire and the heater wire pin.A lot check was not performed as lot information was not provided.Resistance tests and visual inspections are performed on all breathing circuits during production and those that fail are rejected.This suggests that the heater wire resistance became open circuit after the product was released for distribution.(b)(4).Discarded by hospital.

• 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: 4383118
• MDR Text Key: 5262845
• Report Number: 9611451-2015-00003
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT210
• Device Catalogue Number: RT210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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