MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT INSPIRATORY HEATED BREATHING CIRCUIT; BTT

Model Number RT114

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt114 adult inspiratory heated breathing circuit was not available to be returned to fisher & paykel healthcare in (b)(4) for investigation.We are currently in the process of obtaining further information for investigation.We will submit a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported that sparking was observed at the chamber (distal) end of an rt114 adult inspiratory heated breathing circuit during use with an hc550 f&p heated humidifier.There was no damage to the rt114 circuit prior to or after the sparking.It was reported that the hc550 humidifier grew abnormally hot near the back of the device and had given a high temperature alarm the night before the incident.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint rt114 adult inspiratory heated breathing circuit was not available to be returned to fisher & paykel healthcare in new zealand for investigation, however the hc550 heated humidifier that was used in the reported event was returned.Our investigation is thus based on the information provided by the customer, our knowledge of the product and performance testing tof the hc550 heated humidifier.Results: the subject hc550 heated humidifier passed all calibration and performance checks.No fault was found with the subject humidifier.Conclusion: without the return of the complaint breathing circuit, we are unable to determine the cause of the arcing.However, the information provided by the customer indicates that the arcing was confined to the pin heater wire connection inside the overmoulded heater wire plug.The heater wire adaptor (900mr806) is an electrical adaptor used for connecting a heated breathing circuit with the hc550 humidifier, and incorporates a surge and over-current protection circuitry.In the event of a power surge, the adaptor disconnects the heater wire for up to four seconds and the hc550 humidifier will alarm.The adaptor will then reconnect the heater wire and resume normal operation.The information provided by the customer indicated that the heater wire adaptor functioned as intended.The user instructions for the rt114 adulty inspiratory heated breathing circuit state the following: - check all connections are tight before use - set appropriate ventilator alarms.

Event Description

A hospital in california reported that sparking was observed at the chamber (distal) end of an rt114 adult inspiratory heated breathing circuit during use with an hc550 f&p heated humidifier.There was no damage to the rt114 circuit prior to or after the sparking.It was reported that the hc550 humidifier grew abnormally hot near the back of the device and had given a high temperature alarm the night before the incident.There was no patient consequence.

• Brand Name: ADULT INSPIRATORY HEATED BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 7529057
• MDR Text Key: 108741397
• Report Number: 9611451-2018-00424
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/21/2018

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: RT114
• Device Catalogue Number: RT114
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 04/21/2018
• Supplement Dates FDA Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: F&P 900MR806 HEATER-WIRE ADAPTER; F&P 900MR806 HEATER-WIRE ADAPTER; F&P 900MR869 TEMPERATURE PROBE; F&P 900MR869 TEMPERATURE PROBE; F&P HC550 HEATED HUMIDIFIER; F&P HC550 HEATED HUMIDIFIER; TRILOGY 100 VENTILATOR; TRILOGY 100 VENTILATOR; F&P 900MR806 HEATER-WIRE ADAPTER; F&P 900MR869 TEMPERATURE PROBE; F&P HC550 HEATED HUMIDIFIER; TRILOGY 100 VENTILATOR