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

Model Number MR850

Device Problems Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 05/05/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The complaint mr850 respiratory humidifier was returned to our service centre in the (b)(4) where it was inspected by a trained fph service engineer.No fault was found with the complaint device.We are currently in the process of obtaining further information from the customer, to determine if our product caused or contributed to the reported event.We will submit a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare representative that a patient desaturated whilst using a mr850 respiratory humidifier in conjunction with a (b)(4) cf800 continuous flow cpap system.The patient set-up involved an intersurgical breathing circuit and an intersurgical humidification chamber.It was reported that the inspiratory limb became disconnnected from the humidification chamber and the patient entered respiratory arrest.

Manufacturer Narrative

(b)(4).Method: the complaint mr850 respiratory humidifier was returned to the fisher & paykel healthcare service centre in the (b)(6), where it was inspected and performance checked by a trained service engineer (as per the product technical manual).Our investigation is accordingly based on the service report from the service centre, our knowledge of the product and information reported by the hospital.Results: no fault was found with the subject mr850 respiratory humidifier during the performance check.The hospital reported that an intersurgical breathing circuit and an intersurgical humidification chamber was used, with the disconnection occurring between the inspiratory limb and chamber.Conclusion: no fisher & paykel healthcare product was found to cause or contribute to the reported incident.The cause of the incident was a disconnect between the intersurgical brand inspiratory limb and intersurgical brand chamber.The mr850 respiratory humidifier is used to warm and humidify gases delivered to patients requiring mechanical ventilation, positive pressure breathing assistance or medical gases.The subject mr850 was found to operate normally and within specification during the performance check.The user instructions and product technical manual for the mr850 respiratory humidifier both 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.' therefore, based on the investigation conducted and the information reported by the hospital, we conclude that the mr850 respiratory humidifier did not cause or contribute to the reported event.(note: an initial report was submitted as fisher & paykel healthcare was still gathering further information on the reported incident at the time.The investigation has since established that the mr850 respiratory humidifier did not cause or contribute to the reported incident, and this final report is meant to provide closure of the initial report.).

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare representative that a patient desaturated whilst using a mr850 respiratory humidifier in conjunction with a draeger cf800 continuous flow cpap system.The patient set-up involved an intersurgical breathing circuit and an intersurgical humidification chamber.It was reported that the intersurgical brand inspiratory limb became disconnected from the intersurgical brand humidification chamber and the patient entered respiratory arrest and died.

• 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 ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 5749307
• MDR Text Key: 48189293
• Report Number: 9611451-2016-00269
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K073706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MR850
• Device Catalogue Number: MR850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death