MAUDE Adverse Event Report: RESMED LTD QUATTRO AIR FFM MED-AMER; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 62702

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

The masks have been received by resmed and an evaluation was performed.The evaluation confirmed that the non-vented quattro air nv masks had an exterior packaging labelled as a vented quattro air full face mask system.No device was involved in an adverse event.The design authority, resmed ltd, has thoroughly investigated the mask labeling issue and the root cause has been isolated to mask packaging on a single rework.The physical masks, vented quattro air and non-vented quattro air, are clearly distinguishable in form and color as well as a different elbow connection size.In response to our investigation, resmed is actively reviewing additional containment steps that may be required.(b)(4).

Event Description

It was reported to resmed that 4 non-vented quattro air nv masks had an exterior packaging labelled as a vented quattro air full face mask system.It was reported that the masks were not placed on a patient; therefore, there was no patient involvement.

• Brand Name: QUATTRO AIR FFM MED-AMER
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista, nsw 2153 ; AS 2153
• Manufacturer Contact: david duley ; 9001 spectrum center boulevard; san diego, CA 92123 ; 8588365985
• MDR Report Key: 5873993
• MDR Text Key: 52060192
• Report Number: 3004604967-2016-00894
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/12/2016

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: 62702
• Device Catalogue Number: 62702
• Device Lot Number: 1142623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/13/2016
• Device Age: 6 MO
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2015
• 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