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

Model Number RT380

Device Problems Device Inoperable (1663); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information and the complaint rt380 adult dual heated evaqua2 breathing circuit from the hospital for investigation.We will submit a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a v500 ventilator stopped working during use on a patient.Water was then found in the f&p rt380 adult dual heated evaqua2 breathing circuit.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint rt380 adult dual heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare for evaluation.Further information was sought about the incident and a request was made for the device, but we did not receive any response.Conclusion: the complaint circuit was not returned and there was not enough information provided by the customer to indicate what might have caused the condensation reported.Condensate in the humidification system, although not preferred, 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 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 healthcare facility in denmark reported via a fisher & paykel healthcare (f&p) field representative that a v500 ventilator stopped working during use on a patient.Water was then found in the f&p rt380 adult dual heated evaqua2 breathing circuit.No patient consequence was reported.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 7521355
• MDR Text Key: 108886914
• Report Number: 9611451-2018-00416
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• 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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: F&P MR850 HEATED HUMIDIFIER; F&P MR850 HEATED HUMIDIFIER; F&P OPT944 OPTIFLOW NASAL CANNULA; F&P OPT944 OPTIFLOW NASAL CANNULA; V500 DRAEGER VENTILATOR; V500 DRAEGER VENTILATOR
• Patient Outcome(s): Life Threatening