MAUDE Adverse Event Report: RESMED AIR SENSE 10; CPAP MACHINE

Model Number AIR SENSE 10

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949)

Patient Problems Dyspnea (1816); Anxiety (2328)

Event Date 09/05/2015

Event Type  Injury  

Event Description

Dates of use: (b)(6) 2015.Diagnosis or reason for use: mild sleep apnea.Event abated after use stopped or dose reduced? yes.Event reappeared after reintroduction? yes.Received resmed air sense 10 cpap machine from apria health care this summer and attempted to use the mask and nasal pillows.Developed severe anxiety with shortness of breath which led to cardiac stress test and pulmonary function test.Discovered that if the power is shut off before removing the mask, there is severe resistance to breathing.This is a death trap if someone does not wake up when the machine is accidentally turned off or power is lost in a storm.This is even worse if someone is using a chin strap.

• Brand Name: AIR SENSE 10
• Type of Device: CPAP MACHINE
• Manufacturer (Section D): RESMED; sg
• MDR Report Key: 5185414
• MDR Text Key: 29820683
• Report Number: MW5057370
• Device Sequence Number: 1
• Product Code: BZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2015

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: AIR SENSE 10
• Device Lot Number: 1110657
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR
• Patient Weight: 77