MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED RESPIRATORY HUMIDIFIER; BTT

Model Number HC550JHU

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint hc550jhu respiratory humidifier was not returned to fisher & paykel healthcare (fph) for investigation.Our analysis is accordingly based on the additional information and photographs we received from the healthcare facility.The healthcare facility reported that the temperature probes were not inserted into the ports of the respironics non-heated passive ventilator circuit, which is a non-fph breathing circuit.Consequently, the hc550jhu humidifier kept on reading the ambient temperature and not the temperature of the ventilator circuit.A representative from the quality team of fph office in irvine, california contacted the healthcare facility and advised them that the temperature probes must be inserted into the breathing circuit.No issues were noted after the probes were fitted correctly.The chamber & airway probes indicators on the hc550 humidifier light up if either of the probes is not inserted into the breathing circuit correctly.During start-up or rapid change in temperature, the hc550 humidifier will check if the probe is correctly inserted by cooling and subsequently heating up the probe.If the hc550 humidifier detected that either probes is not or incorrectly inserted into the breathing circuit, an alarm will be generated and the humidifier will enter the stand-by mode.The user instructions illustrate in pictorial format the correct set-up and proper use of the hc550 respiratory humidifier and its accessories.It also state the following: "the use of breathing circuits, chambers or other accessories which are not approved by fisher & paykel healthcare may impair performance or compromise safety." "ensure that both temperature probe sensors are correctly and securely fitted.Failure to do so may result in temperatures in excess of 41 °c being delivered to the patient.".

Event Description

A healthcare facility in (b)(6) reported that an hc550jhu respiratory humidifier, which displayed a temperature of 22.5°c, burned a respironics non-heated passive ventilator circuit.It was also reported that the temperature probe was inserted to the side of the subject humidifier but not into the ventilator circuit.No alarm was observed on the humidifier when the incident occured.This was observed before use on a patient.

• Brand Name: RESPIRATORY HUMIDIFIER
• 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 ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 5690158
• MDR Text Key: 46256423
• Report Number: 9611451-2016-00238
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HC550JHU
• Device Catalogue Number: HC550JHU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1