MAUDE Adverse Event Report: RESMED CORP RESMED AIR MINI; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 619

Device Problem Use of Device Problem (1670)

Patient Problems Fever (1858); Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/08/2023

Event Type  Injury  

Event Description

Used the resmed air mini device for one night, 24 hours later i have a low grade fever, watery eyes, runny nose and a persistent cough, mild headache.This has occurred on two other occasions with the same symptoms.These symptoms resolve within 24 hours.In each instance i was using the air mini at different locations, including my own home.I used the hyde-x plus filter and it was brand new in each case.I have a resmed air sense 10 for her and use it without any issues.

• Brand Name: RESMED AIR MINI
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 16911255
• MDR Text Key: 315112466
• Report Number: MW5117464
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/08/2023

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: 619
• Device Catalogue Number: 38113
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2023
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White