MAUDE Adverse Event Report: RESMED CORP RESMED CPAP F20 MASK ADAPTER; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number F20

Patient Problems Aspiration/Inhalation (1725); Unspecified Infection (1930); Memory Loss/Impairment (1958); Visual Disturbances (2140); Brain Injury (2219); Weight Changes (2607)

Event Date 04/01/2023

Event Type  Injury  

Event Description

Cpap has a filter that is hidden causing mold toxicity in my body.Brain damage proven by mri.And more.I am having memory changes, eyesight changes, body changes, weight gain, mouth infections.

• Brand Name: RESMED CPAP F20 MASK ADAPTER
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 19143158
• MDR Text Key: 340740176
• Report Number: MW5154010
• 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: 04/17/2024

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: F20
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Patient Sequence Number: 1
• Treatment: KISQALI.; LEXAPRO.; LIPITOR.
• Patient Outcome(s): Disability; Life Threatening
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White