MAUDE Adverse Event Report: RESMED CORP. AIRTOUCH F20; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number AIRTOUCH F20 SML

Patient Problems Headache (1880); Nausea (1970); Loss of Vision (2139); Vomiting (2144); Convulsion/Seizure (4406)

Event Date 11/05/2022

Event Type  Injury  

Event Description

In february 2024, learned of the recall of my cpap mask since the magnet has been shown to affect medical devices such as the shunt that i have implanted.I have an cpap machine that i use daily to treat my sleep apnea.Even on the days that i do not use the cpap machine it sits on my nightstand which is a couple inches from my body and shunt.I have a lumbar-peritoneal shunt and in (b)(6) 2022 the shunt stopped working and my csf pressure became high resulting in debilitating headaches, seizures, nausea, vomiting, and loss of vision in my eyes.I had a ct scan that showed that the placement of the shunt was correct and nothing had shifted.My doctor performed a lumbar puncture which came back with a csf pressure that was incredibly high, showing that the shunt was no longer working.In (b)(6) 2023 i had to have a surgical shunt revision to replace the shunt valve.My doctor was baffled and could not figure out why my shunt failed.After this surgery i continued to use and sleep next to me cpap machine/mask.The shunt that was placed in (b)(6) 2023 also failed and required another surgery to fix the problem.In (b)(6) 2023 i had a surgical shunt revision and again the doctor could find no reason why the shunt would have malfunctioned.Following this surgery my doctor still struggled to get the shunt adjusted and i had to have multiple visits to his office where he adjusted it using his medtronic shunt adjustor.I stopped using my cpap machine in (b)(6) 2023 and moved the mask/machine out of my room.Since i discontinued use of the cpap mask i have experienced no problems with my shunt.After receiving a letter in the mail about the recall of my cpap mask, i think it is now clear that the problems and surgeries that i had to have to my shunt are a directly caused from the cpap mask recall.Reference report #mw5153856.

• Brand Name: AIRTOUCH F20
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 19114939
• MDR Text Key: 340397780
• Report Number: MW5153855
• 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: Patient
• Type of Report: Initial

1 Device was Involved in the Event

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 Model Number: AIRTOUCH F20 SML
• Device Catalogue Number: 63000
• Device Lot Number: (10)1654841
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2024
• Patient Sequence Number: 1
• Treatment: ARMOUR THYROID; BYSTOLIC; HYDROCORTISONE; IRON ; KRILL OIL; LUNESTA MEDICAL DEVICES: LUMBAR-PERITONEAL SHUNT; MELATONIN; MULTI-VITAMIN; SPIRONOLACTONE; ZAFIRLUKAST
• Patient Outcome(s): Disability; Other; Hospitalization; Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White