MAUDE Adverse Event Report: RESMED PTY LTD CLIP + BULLE POUR MIRAGE QUATTRO, TAILLE L; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 61293

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2023

Event Type  malfunction  

Event Description

It was reported to resmed that the anti-asphyxia valve flap of a mirage quattro full face mask allegedly dislodged and flew in the patient's face the first night the mask was used.The patient had reportedly wiped the mask inside of the cushion with a wet wipe before first use.There was no patient harm or a serious injury reported as a result of this incident.

Manufacturer Narrative

The mask was returned to resmed for an extensive engineering investigation.The investigation methods, results and conclusion are not finalized at this stage.If more information is available, a supplemental report will be submitted.The mirage quattro user guide provides the following warning: "do not use aromatic-based solutions or scented oils (eg, eucalyptus or essential oils), bleach, alcohol or products that smell strongly (eg, citrus) to clean any of the mask components.Residual vapors from these solutions can be inhaled if not rinsed thoroughly.They may also damage the mask causing cracks." resmed reference#: (b)(4).H3 other text : device received, investigation pending.

• Brand Name: CLIP + BULLE POUR MIRAGE QUATTRO, TAILLE L
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 18889696
• MDR Text Key: 337511314
• Report Number: 3007573469-2024-00064
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 61293
• Device Catalogue Number: 61293
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2024
• Distributor Facility Aware Date: 02/13/2024
• Event Location: Home
• Date Report to Manufacturer: 03/12/2024
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1