MAUDE Adverse Event Report: RESMED LTD QUATTRO FX MEDIUM CPAP MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Product Quality Problem (1506)

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

Event Date 06/10/2020

Event Type  Injury  

Event Description

Pt has resmed quattro fx medium mask and matching headgear, and has had these for quite some time.Headgear wears out within 3 months, requiring pt to buy new one.Even before this, he has to make modifications (sew parts together) because it will not hold.Thus, cpap becomes less effective.Note that (b)(6) covers a new headgear only every 6 months.For most of my patients, most headgears realistically last 9-12 months.Fda safety report id# (b)(4).

• Brand Name: QUATTRO FX MEDIUM CPAP MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED LTD
• MDR Report Key: 10148303
• MDR Text Key: 195153560
• Report Number: MW5094967
• 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: Physician
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention