MAUDE Adverse Event Report: RESMED LTD. AIRSENSE 10 AUTOSET; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Catalog Number 37028

Device Problems Device Alarm System (1012); Gas/Air Leak (2946); Manufacturing, Packaging or Shipping Problem (2975); Pressure Problem (3012)

Patient Problem Dyspnea (1816)

Event Date 10/23/2019

Event Type  Injury  

Event Description

It was reported to resmed (mfr) and (b)(4) that the airsense 10 cpap device caused the user to experience hyperinflation of their lungs and cheeks during use resulting in difficult and painful breathing.The customer received the cpap device 6 months ago.The cause was an air leak between the humidifier water box and the cpap unit when box is inserted into the unit less than a quarter millimeter off set.The customer received the cpap device 6 months ago and recently change the mask and air tubing.The customer stated there is a defect in the design involving the connection between the cpap machine and the humidifier unit.The customer stated even the slightest unseating will cause a change to the air pressure.The customer experienced a change from maximum air pressure to not enough air pressure.He fears that this device needs to be closely considered as many people could die as a result of its malfunction.The problem can start intermittently and the machine does not report an error though it should.He believes that when it occurs it could cause fatality yet a medical examiner would not be able to dictate that a defect was in the design.He alleges that mfr has declined to act on the report as has the distributor who acknowledges many complaints for over a year.He is afraid that reporting this machine as a fatality or an injury is impossible a forensic scientist or medical examiner as the equipment does not give evidence or an error message it would simply stop working after the pt stopped breathing.He stated that the machine he has no idea that it is malfunctioning.

• Brand Name: AIRSENSE 10 AUTOSET
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED LTD.
• MDR Report Key: 9335123
• MDR Text Key: 166978086
• Report Number: MW5091139
• 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: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 37028
• Device Lot Number: 1268088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR