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

Device Problems Fitting Problem (2183); Component Missing (2306)

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

Event Date 02/17/2020

Event Type  malfunction  

Event Description

I had a cpap mask that wasn't fitting correctly so i took it back to the store on a 30 day warranty.They tried to give me a trial mask that clearly been worn with looked to be unsanitary stuff around the nose areas did not look clean at all.Then i told them i want a new one in a bag and they gave me one that was already opened with pieces missing out of it.I was told the original mask would be billed to insurance company, not the new cheaper one and the insurance said they can't bill for the one you don't have.I believe these products being used and open and not saying they are used is a violation of law.When i got the machine it didn't come in a box, new.It was already open in a duffel bag not knowing if it was new or not.Fda safety report id# (b)(4).

• Brand Name: CPAP NASAL MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 9744680
• MDR Text Key: 180902195
• Report Number: MW5093210
• Device Sequence Number: 2
• 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: 02/19/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 110