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

Model Number MR850

Device Problem Device Issue (2379)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The subject mr850 humidifier has been not returned to fisher & paykel healthcare (fph) in (b)(4) for investigation.Our analysis is accordingly based on the additional information provided by the hospital and our knowledge of the product.The subject mr850 humidifier remains at the hospital where the incident occurred.The hospital reported that the subject mr850 was connected to a fabien ventilator and a sebac breathing circuit neither of which are recommended for use with fisher & paykel healthcare humidifiers.It was also reported that the nitric oxide supply failed and patient desaturated.Conclusion: user error contributed to the event.The sebac breathing circuit and the fabien ventilator used with the mr850 humidifier are not approved for use with fph products.Our user instructions that accompany the mr850 respiratory humidifier states: - the use of breathing circuits, chambers or other accessories which are not approved by fisher & paykel healthcare may impair performance or compromise safety.Condensate 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, including use of third party breathing circuits not approved by fph.

Event Description

A hospital in (b)(6) reported that there was a condensation issue on a ventilation system composed of a fabian ventilator, an mr850 and a sebac breathing circuit.The patient's airway needed to be aspirated about 55 times in a 24 hour period.An episode occurred at 1:30 am, when the nitric oxide supply failed and the patient experienced bradycardia followed by rapid oxygen desaturation - medical intervention by hand pump was necessary and a pediatric emergency doctor was required.Additionally the customer reported the presence of burn marks due to humidification.

• 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: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618-2216 ; 9194534000
• MDR Report Key: 7057656
• MDR Text Key: 93441407
• Report Number: 9611451-2017-01096
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR850
• Device Catalogue Number: MR850
• Device Lot Number: 020503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2002
• 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 Age: 2 DA