MAUDE Adverse Event Report: RESMED LTD F20 QUIETAIR ELBOW

Model Number 63494

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation could be performed.Resmed was informed that the device was discarded by the customer, therefore resmed is unable to confirm the alleged malfunction.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.(b)(4).

Event Description

It was reported to resmed that the valves of an f20 quietair elbow were not functioning properly.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: F20 QUIETAIR ELBOW
• 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: 7518825
• MDR Text Key: 108494843
• Report Number: 3004604967-2018-00758
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K153563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 63494
• Device Catalogue Number: 63494
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/17/2018
• Date Manufacturer Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1