MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED INFANT CONTINUOUS FLOW BREATHING CIRCUIT; BTT

Model Number RT329

Device Problems Detachment Of Device Component (1104); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event Description

A hospital in georgia reported via a fisher & paykel healthcare representative that the temperature probe came off the rt329 infant continuous flow breathing circuit leading to an increase in the airflow's temperature.It was further reported that the hot air burned the patient's nose.

Manufacturer Narrative

(b)(4).The complaint rt329 circuit was not returned to fisher & paykel healthcare for evaluation.Additional information has been requested from the hospital in order to complete the investigation.We are currently investigating whether the burn is a pressure mark.A follow up report will be provided upon completion of our investigation.

Manufacturer Narrative

(b)(4).The complaint rt329 circuit was not returned to fisher & paykel healthcare for evaluation.Additional information was requested from the hospital and a fisher & paykel healthcare representative met with the customer to discuss the incident.It was determined that the temperature probe was not inserted correctly as per the user instructions; the incorrect set up is most likely the reason for the disconnection of the temperature probe from the rt329 circuit.A disconnected temperature probe would have caused an increase in the air's temperature, as reported.The injury described was two marks on the top of the nose where the flow exited the prong.The patient's parent had removed the bc cannula from the nare and placed it on top of the nose.The fisher & paykel healthcare representaive is working with the customer to develop an action to plan to address this user error.Under correct setup, the temperature probe and the rt329 circuit comply with iso8185:2007.The user instructions that accompany the rt329 circuit contain a pictorial diagram that shows how to connect the temperature probe to the rt329 circuit correctly.The user instructions also state the following: "check that all connections, caps and/or plugs are tight before use"; "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient."; "patient monitoring is recommended."; "set appropriate ventilator alarms.".

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare representative that the temperature probe came off the rt329 infant continuous flow breathing circuit leading to an increase in the airflow's temperature.It was further reported that the hot air burned the patient's nose.

• Brand Name: INFANT CONTINUOUS FLOW BREATHING CIRCUIT
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine; 9494534000
• MDR Report Key: 4157753
• MDR Text Key: 20458715
• Report Number: 9611451-2014-00804
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT329
• Device Catalogue Number: RT329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2014
• 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
• Treatment: FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER; FISHER & PAYKEL HEALTHCARE MR850 HUMIDIFIER