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

Model Number RT340

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 01/09/2015

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare field representative that an rt340 adult dual-heated evaqua breathing circuit was causing the mr850 humidifier to alarm.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint inspiratory limb of the rt340 adult dual-heated evaqua breathing circuit was returned to fisher & paykel healthcare in (b)(6) for evaluation.The inspiratory heater wire was resistance tested using a calibrated multimeter.Results: the resistance test revealed that the inspiratory heater wire was out of specification.Continuity testing and visual inspection revealed that the open circuit in the inspiratory heater wire was due to a break in the connection between the heater wire and the right heater wire pin inside the overmoulded plug.A lot check revealed no other similar complaints of this nature for lot 140801.Conclusion: we are unable to determine what may have caused the observed damage on the inspiratory heater wire.Resistance tests and visual inspections are performed on all breathing circuits during production.Any circuit that fails is rejected.This suggests that the heater wire became open circuit after it was released for distribution.The customer has confirmed that the subject breathing circuit was in use for two days before a mr850 alarm was observed, which indicates that the circuit became damaged during use.The user instructions that accompany the rt340 adult dual heated evaqua breathing circuit state the following: - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "set appropriate ventilator alarms".(b)(4).

• Brand Name: ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216
• MDR Report Key: 4453484
• MDR Text Key: 16557835
• Report Number: 9611451-2015-00034
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT340
• Device Catalogue Number: RT340
• Device Lot Number: 140801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2015
• Date Manufacturer Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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
• Treatment: FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER