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

Patient Problems Dyspnea (1816); Headache (1880); Itching Sensation (1943); Sneezing (2251); Sore Throat (2396)

Event Type  Injury  

Event Description

Becoming short of breath, itching, nose, irritated throat, nose running constantly, sneezing.Having headaches now.My doctor says keep using the cpap(continuous positive airway pressure.

• Brand Name: AIRSENSE 11 AUTOSET
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 17932097
• MDR Text Key: 325728941
• Report Number: MW5146934
• 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: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALOGLIPTIN; ASPIRIN ; ATORVASTATIN ; D3; FUROSEMIDE ; JARDIANCE; METFORMIN
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Race: Black Or African American