MAUDE Adverse Event Report: RESMED CORP RESMED AIRCURVE 10 VAUTO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Contamination (1120)

Patient Problems Bacterial Infection (1735); Dyspnea (1816)

Event Date 12/26/2022

Event Type  Injury  

Event Description

Awoke with shortness of breath.Was using resmed aircurve10 vauto bipap.Required thoracentesis, decortication of lungs and over 3 weeks hospitalization and rehabilitation.After returning to home and resuming use i looked inside the chamber holding the reservoir and observed bacterial biofilms and mold colonies both in the chamber and on the silicone bushings connecting the inner machine parts with the chamber.I deconned the machine surfaces with bleach and called resmed to find out how to decon the inner parts and was informed that they never had any problems of this kind and the problem was the distributers (b)(4).My physician (dr.(b)(6)) advised me to stop use and bag the machine to prevent further contamination.He will order a new machine if the insurance will pay for it.I have contacted medical device attorneys and will initiate a lawsuit because of the indifference and hubris of the manufacturer.As i am retired i no longer have access to forensic sampling gear so i cannot take nor analyze swabs from the machine.The infectious disease physician was confident that my pulmonary infection was bacterial since iv piperacillin was effective in eliminating the infection.However no clinical cultures were grown from the exudates sampled.He attributed this to the immediate high dose antibiotics i was administered in the emergency room prior to my admission to baptist hospital in miami.I was not administered any antifungals so the mold colonies were unlikely causes of the pulmonary infection.The machine and components are bagged in a polyethylene ziplock bag.

• Brand Name: RESMED AIRCURVE 10 VAUTO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 16630814
• MDR Text Key: 312299394
• Report Number: MW5116044
• 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: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ARGININE,; CIALIS; DESVENLAFAXINE; FLUTICASONE NASAL SPRAY; GABAPENTIN ; LORAZEPAM; LOSARTAN; MITRAGYNA SPECIOSA; MULTIVITAMIN; TESTOSTERONE INJ
• Patient Outcome(s): Disability; Life Threatening; Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native