MAUDE Adverse Event Report: RESMED LTD RESMED CPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number ESCAPE II

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2019

Event Type  No Answer Provided  

Event Description

I use a cpap rn machine.There appears to be an underlining problem with bacterial growth on masks during use.The positive air pressure works well by keeping the airways open.At the same time, the open airways during use also deposit biological material on the inside of the mask.During sleep and use of just a few hours, the mask becomes a virtual petri dish.Bacteria grows on the inside of the mask and releases waste and higher concentrations of bacteria to be inhaled into the open airways.This may not be of any concern except for cpap users who may be susceptible to infections.The airway into lungs may provide a pathway for harmful concentrations of bacteria to enter the blood stream.The most meticulous users sanitizing their equipment each day cannot prevent the possible exposure to potential harmful bacteria growth during use.Thus far, i am unable to locate any helpful information to remedy this potential problem.The problem is non-specific to a manufacturer and appears to affect all cpcp masks.If your organization has considered methods of reducing the risk of exposure to bacteria growth inside the cpap mask during use, please let me know.I appreciate your review of my concern.(b)(4).

• Brand Name: RESMED CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED LTD
• MDR Report Key: 9465876
• MDR Text Key: 171794727
• Report Number: MW5091634
• 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: Unknown
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ESCAPE II
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1