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

Model Number RT380

Device Problem Moisture Damage (1405)

Patient Problem No Code Available (3191)

Event Date 03/31/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt380 adult dual-heated evaqua2 breathing circuit was returned to fisher & paykel healthcare (fph) in (b)(4) for investigation.The inspiratory and expiratory heater wire of the circuit was resistance tested using a calibrated multimeter.Results: the resistance test revealed that the inspiratory and expiratory heater wire on the returned circuit was within specification.A lot check revealed no other complaints of this nature for lot 150304.Conclusion: following this incident, an fph representative visited the hospital and obtained further information and offered advice to address the reported condensation issue.The fph representative noticed that the temperature in the affected room was 25 to 27 degrees celsius, which is very warm.This temperature is at the upper end of the mr850 humidifier operating conditions of 18 to 26 degrees celsius, stated in the mr850 user instruction.A high room temperature potentially can contribute to excessive condensation, thus room temperature monitoring is essential.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.Since the fph representative visited the hospital, we have received no further reports relating to condensation issues.The user instructions that accompany the mr850 state the following: operating conditions: recommended ambient temperature 18 - 26 °c.Caution: if operating in ambient temperatures outside the recommended range, consult your local fisher & paykel healthcare representative or consult the technical manual.The user instructions that accompany the rt380 state the following: set appropriate ventilator alarms.Check breathing circuits for condensation every 6 hours and drain if required.

Event Description

A hospital in (b)(6) reported that an intubated patient had bronchial congestion allegedly due to condensation in the humidification system.Condensation was noticed in the expiratory limb of an rt380 adult dual heated evaqua2 breathing circuit.The subject breathing circuit was used in conjunction with a drager ventilator.

• 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: 4789928
• MDR Text Key: 19069713
• Report Number: 9611451-2015-00245
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• 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: 150304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2015
• Date Manufacturer Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2015
• 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; DRAGER VENTILATOR