MAUDE Adverse Event Report: RESMED QUATTRO AIR MEDIUM CUSHION MASK

Model Number	62738
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Ordered 2 resmed medium size replacement cushions ((b)(4)) for my resmed quattro air mask from amazon seller (b)(4), i opened the first sealed plastic container and noticed a strong chemical smell.There have been no such smells in my 7 years of using resmed cpap machines, cushions or masks.I washed the cushion (which includes the plastic mask) in warm water and soap.It made no difference.I noticed that the packages of all 5 masks say "made in (b)(6)".I am concerned that these are either defective or counterfeit.I opened another cushion that i ordered from another seller on amazon.I was perfectly fine.No smell at all.The package said it was made in (b)(6).

• Brand Name: QUATTRO AIR MEDIUM CUSHION MASK
• Common Device Name: MASK
• Manufacturer (Section D): RESMED
• MDR Report Key: 7334166
• Report Number: MW5075813
• Device Sequence Number: 10916139
• Product Code: BZD
• UDI-Device Identifier: 00619498627387
• UDI-Public: 00619498627387
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 62738
• Device Catalogue Number: 62738
• Device Lot Number: 1245884
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2018
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 79