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

Model Number 39001

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001)

Patient Problem Cough (4457)

Event Date 09/30/2022

Event Type  Injury  

Event Description

Concerning a resmed airsense 11 cpap machine used to treat sleep apnea, i went to sleep using the mask.I woke up coughing and gagging during the middle of the night and water was leaking from the hose after i took the mask off.I have my cpap machine placed in my nightstand in a drawer which i partially close during the night because the light coming from the machine bothers me.I opened the drawer and found the machine light was not on.I found that the plug adapter somehow disconnected from the wall outlet.Redmed uses a two-prong rather than a three-prong adapter.It seems to me that if the unit came with a more-modern three-prong adapter, this may have not happened because this type of adapter is less prone to disconnecting from a wall outlet.Fda safety report id# (b)(4).

• Brand Name: AIRSENSE 11
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 15537226
• MDR Text Key: 301185764
• Report Number: MW5112403
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498394852
• UDI-Public: (01)00619498394852
• 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
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 39001
• Device Catalogue Number: 39001
• Device Lot Number: 1618387
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: 30 GAUGE ONE TOUCH VERIO TEST STRIPS; 30 GAUGE ONE TOUCH VERIO TEST STRIPS; 30 GAUGE ONE TOUCH VERIO TEST STRIPS ; ATORVASTATIN 20 MG ; CETIRIZINE 10 MG ; CLOTRIMAZOLE 1% TOPICAL CREAM ; COENZYME Q-10 200 MG ; COLLOIDAL OATMEAL CREAMD NATURE MAID TRIPLE PROBIOTIC; DICLOFENAC 1 % GEL ; EMPAGLIFLOZIN 10 MG TABLET ; FEXOFENADINE HCL 180 MG ; GINKGO BILOBA 120 MG ; KERASAL MG217 2% ; LAMOTRIGINE 200 MG ; METFORMIN HCL 1000 MG ; MUPIAOCIN 2% OINTMENT ; OMEPRAZOLE 40 MG CAPSULE ; ONE TOUCH DELICA LANCETS ; ONE TOUCH DELICA LANCETS ; REFRESH OPTIVE MEGA-3 EYE DROPS ; REFRESH RELIVA EYE DROPS ; SERTRALINE HCL 100MG ; TIMOLOL MALEATE 0.5 % SOLN ; TRAZODONE 50 MG TABLET ; TRULICITY 1.5 MG/0.5 ML ; VITAMIN D-3 10,000 IU
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian