MAUDE Adverse Event Report: RESMED CORP AIRFIT N30I CUSHION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Device Markings/Labelling Problem (2911); Packaging Problem (3007)

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

Event Date 05/27/2022

Event Type  malfunction  

Event Description

I suffer from obstructive sleep apnea and use a cpap machine as prescribed by my sleep doctor.I recently ordered new supplies for my cpap machine from my dme provider, hme fulfillment llc based in (b)(6).The order consisted of a tube, filters, resmed nasal mask starter kit, and resmed n30i nasal cushions.The nasal cushions all arrived individually packaged in a zip lock bag with no manufacturer labeling.The resmed nasal mask starter kit was opened and the nasal cushions that were meant to be there as part of a standard starter kit were missing.I called up resmed and they confirmed that the nasal cushions should always be packaged and sealed individually, and include a medical label.My guess is that the dme is opening up the starter kits and keeping all the extra nasal cushions that are not of the size that they believe their customer uses and are repackaging these up for sale.This is clearly illegal and in essence constitutes insurance fraud as well as my insurance company is billed for individual brand new nasal cushions and not repackaged ones from starter kits.Fda safety report id # (b)(6).

• Brand Name: AIRFIT N30I CUSHION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 14602218
• MDR Text Key: 293522232
• Report Number: MW5110115
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian