MAUDE Adverse Event Report: RESMED CORP. RESMED MIRAGE SOFT GEL NASAL MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Catalog Number 61601

Device Problems Defective Device (2588); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 12/24/2020

Event Type  Injury  

Event Description

Recently purchased a resmed mirage soft gel face mask to replace old mask for use with a cpap device used for sleep apnea.The clip that holds the cushion in place is curved upward at the bottom, allowing air to escape.The cushion is missing a lip that would normally help hold the cushion in place in the same area as the curved clip.Both defects result in a reduction in air pressure.This can cause the patient to have lack of sleep, stroke, heart attack, and death.The air seepage causes noise that prevents sleep.Fda safety report id# (b)(4).

• Brand Name: RESMED MIRAGE SOFT GEL NASAL MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 11125187
• MDR Text Key: 225521194
• Report Number: MW5098675
• Device Sequence Number: 1
• Product Code: BZD
• 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: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 61601
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 64 YR
• Patient Weight: 136