MAUDE Adverse Event Report: RESMED AIRFIT F30 CUSHION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Product Quality Problem (1506); Component Missing (2306)

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

Event Date 08/12/2022

Event Type  malfunction  

Event Description

For the second time i received in the mail defective, obviously fake cpap products.Product received included apparently okay products, but three of the cpap parts were obviously counterfeit.Someone is making a lot of money selling the real ones and substituting the inadequate nonworking fake parts.Also, the problem started developing after i was switched to another cpap machine.The first machine was by resmed.The current machine has 3b luna g3 on the front of it.I always get these through (b)(6) hospital in (b)(6).But specifically through (b)(6).Mine are paid for through our medicare supplement.The part in question: item 64150 airfit f30 cushion: small.Qty ord 3.The cushion is the exact shape of the real one but cannot be used.It is missing certain holes and attachments needed so i can attach it to the strap and other part and use the new cpap machine with it.This incomplete part would be extremely easy to manufacture cheaply.I suspect someone is selling the real ones online and making a ton of money.Therefore: when i called (b)(6) to complain, i told the clerk the return address which she did not recognize, then she said ¿oh, you¿ve been switched to (b)(4), let me switch you to (b)(4),¿ before i could say anything else.She switched me and i then got a recording hat simply said ¿no routes found,¿ and a hang-up.Return address on the package i received today: (b)(4).Sales id: [part of cpap device] note resmed mask fits the new cpap machine.

• Brand Name: AIRFIT F30 CUSHION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED
• MDR Report Key: 15265892
• MDR Text Key: 298471780
• Report Number: MW5111623
• Device Sequence Number: 3
• 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: 08/12/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CURRENT PRESCRIPTION MEDICATIONS: METFORMIN, ZETIA, METOPROLOL, ZOLOFT GENERIC, ETC.; OVER-THE-COUNTER MEDICATIONS: VITAMIN D3, VITAMIN C, IRON, MULTIVITAMIN FOR WOMEN. EXCEDRIN FOR HEADACHES.
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White