MAUDE Adverse Event Report: RESMED LTD MIRAGE QUATTRO FFM MED-EUR1

Model Number 61206

Device Problem Product Quality Problem (1506)

Patient Problem Abrasion (1689)

Event Type  malfunction  

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that a patient sustained deep facial abrasion and was bleeding as a result of falling out of bed while wearing a mirage quattro full face mask.There was no serious patient injury reported as a result of this incident.

Manufacturer Narrative

The mirage quattro full face mask was returned to resmed for an engineering investigation.The investigation determined that there was no fault found with the returned mask.Resmed's risk analysis for the use of this product remains acceptable.(b)(4).

Event Description

It was reported to resmed that a patient sustained deep facial abrasion and was bleeding as a result of falling out of bed while wearing a mirage quattro full face mask.There was no serious patient injury reported as a result of this incident.

• Brand Name: MIRAGE QUATTRO FFM MED-EUR1
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer (Section G): RESMED CORP; 9001 spectrum center blvd; san diego CA 92123
• Manufacturer Contact: ariana beck ; 9001 spectrum center blvd; san diego, CA 92123
• MDR Report Key: 7123098
• MDR Text Key: 95074596
• Report Number: 3004604967-2017-01790
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K123979
• 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,Followup
• Report Date: 03/21/2018

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: Lay User/Patient
• Device Model Number: 61206
• Device Catalogue Number: 61206
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/13/2018
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 03/13/2018
• Supplement Dates FDA Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1