MAUDE Adverse Event Report: RESMED LTD AIRCURVE 10 ST-A USA CO

Model Number 28210

Device Problem Device Stops Intermittently (1599)

Patient Problem Respiratory Distress (2045)

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 yet been returned, therefore resmed is unable to confirm the alleged malfunction at this time.(b)(4).

Event Description

It was reported to resmed that an aircurve 10 device intermittently powered down on a als patient diagnosed with pneumonia.The patient had increased levels of carbon dioxide and went to an intensive care facility to be evaluated.The patient was later admitted to the hospital.

• Brand Name: AIRCURVE 10 ST-A USA CO
• 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: 6492364
• MDR Text Key: 72959847
• Report Number: 3004604967-2017-00492
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 28210
• Device Catalogue Number: 28210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/14/2017
• Device Age: 6 MO
• Date Manufacturer Received: 03/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1