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

Model Number MR850

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 08/20/2018

Event Type  Death  

Manufacturer Narrative

Ps287009.Method: the complaint mr850 respiratory humidifier was returned to our fisher & paykel healthcare service centre in (b)(4) where it was inspected and performance checked by a trained service engineer as per the product technical manual.Multiple attempts were made to contact the hospital for further information with regards to the reported event, however no further information was received.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.Conclusion: 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.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.

Event Description

A healthcare facility (b)(6) reported that a patient passed away whilst using the mr850 respiratory humidifier and avea ventilator.There was no malfunction reported with the mr850 respiratory humidifier.

• 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: faranak gomarooni ; 173 technology suite drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 7917224
• MDR Text Key: 121988247
• Report Number: 9611451-2018-00828
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/30/2018

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2004
• 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
• Treatment: AVEA VENTILATOR
• Patient Outcome(s): Death