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

Model Number MR850AEK

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591); Temperature Problem (3022)

Patient Problem Low Oxygen Saturation (2477)

Event Date 05/27/2015

Event Type  malfunction  

Event Description

A hospital in the (b)(6) reported that the mr850aek respiratory humidifier stopped working while being used on a baby, causing the baby's saturation to drop.The hospital engineer checked the subject mr850aek by running it for two hours.The humidifier functioned properly during testing but the heater wire alarm sounded on two separate occasions.It was also reported that the temperature on the humidifier stayed at about 37°c.The temperature dropped but only occasionally.

Manufacturer Narrative

(b)(4).Method: the complaint mr850aek respiratory humidifier, 900mr806 heater wire adaptor, 900mr860 temperature/flow probe, and the rt330 optiflow junior tubing kit were returned to fisher & paykel healthcare (fph) service center in the (b)(4).The returned devices were visually inspected and performance checked, as per mr850 product technical manual, by a qualified fph service engineer.The pcb component of the subject mr850aek and the inspiratory limb of the rt330 kit were subsequently sent to fph in (b)(4) for further investigation.Both components were visually inspected and performance tested for 48 hours with known good test mr850 unit and accessories.The performance check was also conducted as per mr850 product technical manual.Results: no physical damage was observed to any of the returned devices when inspected at fph service centre in the (b)(4).All returned devices functioned normally during performance checked, and no alarm or error code was recorded on the subject mr850aek humidifier.No fault was found with the returned pcb component and inspiratory limb when inspected at fph (b)(4).No error code or alarm was observed during the performance check.A lot check revealed no other complaints of this nature for mr850 humidifiers with lot number 111216.Conclusion: the fault reported by the hospital was not replicated during investigation.We are therefore unable to determine what may have caused the reported problem.All mr850 respiratory humidifiers are visually inspected and tested to meet specification prior to being released for distribution, and those that fail are rejected.Following the inspection at fph service center in the (b)(4), the subject mr850aek humidifier was repaired and returned to the hospital after it passed the performance checks specified on the mr850 product technical manual.

• 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 ; 15365 barranca parkway; irvine; 9494534000
• MDR Report Key: 4948264
• MDR Text Key: 6189456
• Report Number: 9611451-2015-00329
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR850AEK
• Device Catalogue Number: MR850AEK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2011
• 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
• Treatment: RT330 OPTIFLOW JUNIOR TUBING KIT; 900MR860 TEMPERATURE/FLOW PROBE; 900MR806 HEATER WIRE ADAPTOR; OPTIFLOW JUNIOR NASAL CANNULA