MAUDE Adverse Event Report: RES MED / RESMED CORP AIRFIT RESMED N20; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number AIRFIT N20

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Foreign Body In Patient (2687); Heart Failure/Congestive Heart Failure (4446); Unspecified Respiratory Problem (4464)

Event Date 04/01/2022

Event Type  Injury  

Event Description

Has a shunt in heart, experienced a third nerve stroke to his eye.Has continued heart failure, rapidly declining.His lungs have recently shown findings of unknown origin decreasing his lung capacity.On (b)(6) 2018 - heart attack w/ shunt (double bypass).On (b)(6) 2022 - third nerve stroke.On (b)(6) 2023 - diagnosed with afib.On (b)(6) 2023- high blood pressure, decreased lung capacity.On (b)(6) 2024 - lungs showing findings unidentifiable substance.

• Brand Name: AIRFIT RESMED N20
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RES MED / RESMED CORP
• MDR Report Key: 18836738
• MDR Text Key: 337042451
• Report Number: MW5152298
• 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
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AIRFIT N20
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization; Disability; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White