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

Model Number RT266

Device Problem Moisture or Humidity Problem (2986)

Patient Problem Aspiration/Inhalation (1725)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare representative that the rt266 infant dual heated evaqua2 breathing circuit has rainout in the swivel wye.They further reported that a nurse moved the patient and some of the water in the swivel wye went down the patient's trache and caused the patient to aspirate water.

Manufacturer Narrative

(b)(4).Since the reported incident an fph representative has visited the hospital and is working with the hospital staff to determine the root cause and to develop an action plan.Our investigation is currently in progress and we will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Method: the complaint device was not available for evaluation.Therefore, our investigation is based on the information provided by the hospital, previous similar investigations and our knowledge of the product.Results: the hospital reported that there was rainout in the swivel adaptor of an rt266 infant evaqua2 breathing circuit.Conclusion: without the return of the complaint device we are unable to determine what may have caused the reported rainout.If the complaint device was returned it would have been performance tested to check for any excessive condensation.Furthermore, the inspiratory and expiratory heater wires would have been resistance tested with a calibrated multimeter.Condensate in the humidification system, is an expected side effect of heated pass-over humidification systems in many conditions, and may vary between light misting to water droplets that form on the wall of cool breathing circuit tubing.The amount of condensate in the ventilation system is influenced by a number of multiple setup and environmental factors.The user instructions that are accompanied with the rt266 state: "set appropriate ventilator alarms." "check breathing circuit for condensation every 6 hours and drain if required." since the reported incident a fisher & paykel healthcare representative has visited the hospital to discuss the correct set up and use of the rt266 infant evaqua2 breathing circuit.The fph rep is working with the hospital to address the reported condensation issue.

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare representative that the rt266 infant dual heated evaqua2 breathing circuit has rainout in the swivel wye.They further reported that a nurse moved the patient and some of the water in the swivel wye went down the patient's trache and caused the patient to aspirate water.

• Brand Name: INFANT 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: 4157796
• MDR Text Key: 4783632
• Report Number: 9611451-2014-00806
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 09/11/2014

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: RT266
• Device Catalogue Number: RT266
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2014
• Initial Date FDA Received: 10/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA 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