MAUDE Adverse Event Report: RESMED PTY LTD. AIRFIT F20 FRAME SYS LGE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 63462

Patient Problems Electrolyte Imbalance (2196); Myalgia (2238); Discomfort (2330); Convulsion/Seizure (4406); Swollen Lymph Nodes/Glands (4432)

Event Date 09/01/2022

Event Type  Injury  

Event Description

Using resmed magnetic cpap mask f20, my son has a vagal/vagus nerve stimulator.He began to have an increase in a very unusual type of seizures never seen before, these seizures can last for hours and have difficulty stopping or slowing these seizures with oral diazepam.I've reported this several times with his neurologist who decided maybe the seizures were caused by certain medications and decided to stop prescribing them.Yet these seizures persisted leaving me very concerned these continuous would lead to a deadly malignant seizure.My son has also been experiencing since 2022 an increase in muscle pain and tightness, swelling to lymph nodes in his legs causing swelling and discomfort.My son's blood work showed a significant increase in co2.My son has also has been suffering from extreme pain with movements of limbs that he didn't have before 2022.I've been in fear my son could die and no one concerned that i've been voicing my concerns.I contacted (b)(6) yesterday (b)(6) 2024 and told them his pacemaker is a vagus nerve stimulator.They said new cpap kit would be mailed.My son, (b)(6) birth date (b)(6) 1980.My son's doctors have become so frustrated with me over my concerns about the abrupt change in my son's health.I'm hopeful the new equipment will resolve these health problems and i'm concerned if they'll be life long or if these complications can lead to a premature death.(b)(6).

• Brand Name: AIRFIT F20 FRAME SYS LGE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED PTY LTD.
• MDR Report Key: 18630601
• MDR Text Key: 334611833
• Report Number: MW5150995
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 63462
• Device Lot Number: (10)1661220
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: DIAZEPAM.; FAMOTIDINE.; GABAPENTIN.; KLONAZAPAM.; LEVOTHYROXIN.; LORAZEPAM.; MIRALAX.; PREVACID.; PRIMIDONE.; TEGRETOL.; TYLENOL.
• Patient Outcome(s): Required Intervention; Other; Disability
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White