MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT380

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 12/16/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare representative that an mr850 humidifier sounded a heater wire disconnect alarm after one day of use with an rt380 adult dual heated evaqua2 breathing circuit.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint rt380 breathing circuit was returned to fisher & paykel healthcare in (b)(4) for evaluation and was visually inspected.A heater wire resistance test of the inspiratory and expiratory heater wire were carried out using a calibrated multimeter.Results: there was no visible damage to the complaint device.The resistance test revealed that the expiratory heater wire was within specification and the inspiratory heater wire was out of specification.Continuity testing and visual inspection revealed that the high resistance in the inspiratory limb heater wire was due to a poor connection between the heater wire and the connector pins.A lot check revealed no other similar complaints for lot date 140804.Conclusion: high electrical resistance in heater wires can be associated with insufficient connection of the heaterwire and the heaterwire pins during production, such that it is unable to provide continuity during the period of use.All rt380 adult breathing circuits are resistance and continuity tested during production, and those that fail are rejected.This suggests that the subject inspiratory heaterwire malfunctioned after release for distribution.The user instructions that accompany the rt380 adult 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 EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• 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: 4513964
• MDR Text Key: 5533881
• Report Number: 9611451-2015-00068
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122432
• 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: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT380
• Device Catalogue Number: RT380
• Device Lot Number: 1408040301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2015
• Date Manufacturer Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2014
• 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