MAUDE Adverse Event Report: RESMED AIRSENSE 10 AUTOSET; CPAP BREATHING MACHINE

Device Problems Bent (1059); Failure to Read Input Signal (1581); Device Inoperable (1663); Cut In Material (2454)

Patient Problem Sleep Dysfunction (2517)

Event Date 01/23/2017

Event Type  No Answer Provided  

Event Description

This is the resmed airsense 10 cpap machine used for sleep apnea.This machine is very expensive ((b)(6)).The start/stop switch on the machine quit working when i needed to sleep last night.I did try to obtain repair for the machine without success, so in desperation, disassembled the machine to see if i could fix.I found that the button on the outside of the machine pushes a tiny (<4 mm) flexible button against an equally small box containing the switch for the machine.These are located on a motherboard.Because this switch and that flexible button are contained in a weak,two-sided metal container, the container had failed and the switch was bent, severing one of the extremely small wires to the motherboard of the machine.This is not repairable except in a specialty shop.The machine is just over two years old and the warranty is for only two years.This problem is one which is dangerous for those of us with sleep apnea, i will now have two nights (and probably more) without proper sleep and will be at risk for the long trip i need to take driving in 4 days.The airsense 10 autoset self-adjusting device is indicated for the treatment of obstructive sleep.Purchase date: 10/01/2014.Document number: i1710538a.Report number: 20170124-1ae91-2147407705.

• Brand Name: AIRSENSE 10 AUTOSET
• Type of Device: CPAP BREATHING MACHINE
• Manufacturer (Section D): RESMED
• MDR Report Key: 6307482
• MDR Text Key: 66821574
• Report Number: MW5067698
• 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: Patient
• Type of Report: Initial
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR