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

Model Number 37090

Device Problems Leak/Splash (1354); Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535); Infusion or Flow Problem (2964)

Patient Problem Dyspnea (1816)

Event Date 05/21/2021

Event Type  malfunction  

Event Description

This is in regards to a cpap machine malfunction, which provided erroneous readings to the patient and doctor, and impeded the ability of the device to supply sufficient air pressure to the patient.I was prescribed a cpap in (b)(6), a resmed airsense autoset machine, from my doctor.The machine has a cell phone app which provides daily readings of how long the cpap is used, as well as other metrics including "leak rate" which is indicative of quality of mask fit.A normal level is a low leak rate (<16 l/min is the "best" score in app).After a few months of usage, i noticed the leak rate gradually decreased to "0 l/min" which is reported as a perfect fit, but which seemed odd as a couple times the mask had come loose but it still registered as "0".My doctor's office advised me that this was normal for this machine.After insisting on a warranty replacement from my doctor, i realized that this erroneous reading that gradually appeared coincided with poor performance of the device that might cause breathing problems for some patients.The air flow from the malfunctioning device had been unable to keep up with rapid inhalation, resulting in the emergency valves in the mouthpiece opening (essentially fighting your ability to inhale).Since this poor performance had appeared gradually along with the decreasing leak rate, i didn't realize these issues until switching to a replacement.All readings on the malfunctioning device's display and app said it was functioning perfectly at the time.I am concerned this could be a design defect that may impact other patients, as the doctors office had told me these "0 l/min" readings were not unusual.Fda safety report id # (b)(4).

• Brand Name: AIRSENSE 10 AUTOSET
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 11929699
• MDR Text Key: 254377187
• Report Number: MW5101670
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498370900
• UDI-Public: (01)00619498370900
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 37090
• Device Lot Number: 1481514
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 74