MAUDE Adverse Event Report: RESMED LTD QUATTRO AIR FFM LGE-EUR1

Model Number 61220

Device Problem Partial Blockage (1065)

Patient Problems No Consequences Or Impact To Patient (2199); Obstruction/Occlusion (2422)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed for an extensive engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.(b)(4).

Event Description

It was reported to resmed (b)(4) that while a medical technician was setting-up a patient on a resmed full face mask the patient stated they could not breath comfortably.The patient was given another new mask and reported the new mask worked without discomfort.There was no patient injury reported as a result of this incident.

Manufacturer Narrative

An extensive engineering investigation was performed on the returned full face mask by resmed.Visual inspection of the mask revealed that contaminants were blocking the vent holes.The investigation determined that reported event was due to improper maintenance of the mask.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.(b)(4).

Event Description

It was reported to resmed (b)(4) that while a medical technician was setting-up a patient on a resmed full face mask the patient stated they could not breath comfortably.The patient was given another new mask and reported the new mask worked without discomfort.There was no patient injury reported as a result of this incident.

• Brand Name: QUATTRO AIR FFM LGE-EUR1
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney 2153 ; AU 2153
• Manufacturer (Section G): RESMED CORP; 9001 spectrum center blvd; san diego CA 92123
• Manufacturer Contact: david duley ; 9001 spectrum center blvd; san diego, CA 92123
• MDR Report Key: 6226517
• MDR Text Key: 64353765
• Report Number: 3004604967-2017-00027
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 61220
• Device Catalogue Number: 61220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/05/2017
• Date Manufacturer Received: 02/05/2017
• 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