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

Model Number HC550

Device Problems Device Alarm System (1012); Partial Blockage (1065)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

A doctor from hospital (b)(6) reported that a patient had thick secretions when using an hc550 respiratory humidifier at home with an rt265 infant dual-heated evaqua2 breathing circuit.They further reported that the hc550 generated humidity alarms.Upon requesting further information, the doctor reported to us on (b)(6) 2014 of an incident where the thick patient secretions allegedly blocked the patient's trache interface.No patient consequence was reported.

Manufacturer Narrative

(b)(4).We are in the process of gathering further information from the hospital.Our investigation is currently in progress and we will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Method: the complaint hc550 respiratory humidifier was not returned to fisher & paykel healthcare (fph) for evaluation.Therefore, our investigation is based on the information provided by the hospital, previous similar investigations and our knowledge of the product.Results: the customer further reported that the hc550 was being used with an rt265 high flow infant breathing circuit at a flow rate of approximately 1 l/min and that condensation was noted in the breathing circuit.They also reported that the humidifier generated the low humidity alarm multiple times.A lot check could not be carried out as the lot number was not provided by the customer.Conclusion: the user instructions that accompany the rt265 high flow infant breathing circuit and the rt266 low flow infant breathing circuit indicate that the rt265 should be used for flow rates greater than 4 l/min and the rt266 should be used for therapy delivered between 0.3 - 4 l/min.The problem reported by the customer was most likely caused by incorrect set up of the breathing circuit and humidifier.Condensation 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 set up and environmental factors.The customer also reported that a window may have been opened.The hc550 user instructions indicate that the low humidity alarm may be caused by cold/draughty conditions.Since the reported incident an fph representative has been in contact with the customer to answer any questions.We are in the process of informing the customer of the correct set up of fph breathing circuits and humidifiers.No patient consequence was reported.

Event Description

A doctor from hospital (b)(6) reported that a patient had thick secretions when using an hc550 respiratory humidifier at home with an rt265 infant dual-heated evaqua2 breathing circuit.They further reported that the hc550 generated humidity alarms.Upon requesting further information, the doctor reported to us on (b)(6) 2014 of an incident where the thick patient secretions allegedly blocked the patient's trache interface.No patient consequence was reported.

• Brand Name: RESPIRATORY HUMIDIFIER
• Type of Device: BTT
• 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: 4233865
• MDR Text Key: 5069375
• Report Number: 9611451-2014-00845
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K132017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HC550
• Device Catalogue Number: HC550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2015
• 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: Reuse
• Patient Sequence Number: 1