MAUDE Adverse Event Report: RESMED LTD NV UMFFM SYS MED STD-EUR1; MASK, OXYGEN

Model Number 60645

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

Patient Problem Death (1802)

Event Date 12/31/2015

Event Type  Death  

Manufacturer Narrative

An investigation carried out by the (b)(4) hospital determined that there was no malfunction with the mask.It was reported that the physician accepted most likely cause of death was from a leak from the patient's circuit.The mask was not returned to resmed for investigation.(b)(4).

Event Description

It was reported to resmed (b)(4) that a hospital patient passed away due to a circuit disconnection while using a resmed ultra mirage nv full face mask with a carefusion ventilator.

• Brand Name: NV UMFFM SYS MED STD-EUR1
• Type of Device: MASK, OXYGEN
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista, nsw 2153 ; AS 2153
• Manufacturer Contact: david duley ; 9001 spectrum center blvd; san diego, CA 92123 ; 8588365985
• MDR Report Key: 5397488
• MDR Text Key: 37058871
• Report Number: 3004604967-2016-00065
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/28/2016

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: Lay User/Patient
• Device Model Number: 60645
• Device Catalogue Number: 60645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/31/2015
• Initial Date Manufacturer Received: 12/31/2015
• Initial Date FDA Received: 01/28/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death