MAUDE Adverse Event Report: RESMED CORP RESMED 11 CPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Lot Number 1547775

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Fatigue (1849); Memory Loss/Impairment (1958); Malaise (2359); Depression (2361); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)

Event Date 12/19/2021

Event Type  Injury  

Event Description

I have sleep apnea since approximately 2003.I was using a philips system one unit since 2013 (this is one of the recalled units).When the recall happened i contacted my dme and was eligible get a new unit so my pcp ordered one.The only unit available was resmed 11, i started using the new unit on (b)(6) 2021.From that time till (b)(6) 2021.I had experienced a decline in my health.I never associated any of my health issues to the unit due to the fact i have used cpap machines and never had a problem.In trying to find the cause of my health issues, i decided to stop using the resmed unit and go back to my philips unit.There was a noticeable improvement in my health after one night on not using the unit.My return to health continued during my trial of not using the resmed.At the advise of dr (b)(6) , i did a trial of using the resmed 11.On (b)(6) i attempted to use the resmed again.In just the 1st night, i woke up feeling like i didn't sleep and was not rested at all.It feels as if i was sedated.I continued to use the machine through (b)(6).I had to stop because again, my health was declining.During this time the health issues i had experienced and would gradually get worse over time were: fatigue, confusion, memory loss, difficulty concentrating, word recall, sequencing, lack of motivation, agitation, unable to provide normal self care.After several months of this i then became depressed and tearful.All of this went away when i stopped using the resmed 11 unit.I did call resmed and reported this and they were not any help.They instructed me to call my dme provider or the ordering physician.At first, the dme was not helping because per their reports the cpap is working and decreasing the number of incidents of apnea.We have ruled out that the machines setting are causing any issues because it is set identical to the philips unit.We also ruled out that there was and issue with the tubing and nasal pillow because i used the same hose and pillow on both units.I also changed the filter.I know for a fact that something with this unit is having a negative affect on my health and me being able to function daily.My unit was manufactured in singapore.Fda safety report id # (b)(4).

Event Description

Add'l info received from reporter on 01/11/2022 for mw5106261.

• Brand Name: RESMED 11 CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 13087361
• MDR Text Key: 282815951
• Report Number: MW5106261
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/11/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 1547775
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2022
• Patient Sequence Number: 1
• Treatment: I DO HAVE LISINOPROL 10 MG, BUT HAVE STOPPED DUE TO DECREASE IN BLOOD PRESSURE SINCE WEIGHT LOSS.; I DO HAVE PRN MEDICATIONS THAT I RARELY USE.; MULTI MINERAL CALCIUM TABLET. ; NEUPOGEN 3X WEEKLY; VITAMIN D; WILL OCCASIONALLY TAKE A MULTI B VITAMIN.
• Patient Outcome(s): Other; Disability
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White