MAUDE Adverse Event Report: RESMED CORP. AIRCURVE 10 VAUTO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Lot Number 1312242

Device Problems Contamination (1120); Material Disintegration (1177); Device Emits Odor (1425); Particulates (1451); Improper or Incorrect Procedure or Method (2017)

Patient Problems Discomfort (2330); Sore Throat (2396)

Event Type  malfunction  

Event Description

I have been on a bi-pap for nearing two years.During this time i had noticed at different times an electrical kind of smell a few times but never consistent.I also had sore throats a few time but again never consistent.I also found myself removing the headgear on different occasions feeling irritated/uncomfortable without knowing why and using again the next day without difficulty.In the past two months or so i started noticing what i thought were mold spores in the water chamber so, i emptied the chamber, washed daily and changed the water.A week ago i noticed material on the discharge side where the unit blew into the chamber.This debris is what i had thought to be mold.Knowing the machine is out of warranty, i took bi-pap apart and found little pieces of material inside the impeller of the blower and in blower housing.Through research online, i found this material is apparently all that was left of media that is internal to unit placed near inlet of the blower.Further checking online i found a recall from respironics for this exact issue.My unit is a resmed, and as of (b)(6) 2021 this is not supposed to be an issue on their units according to statement from resmed posted online.I do have pictures from when i dis-assembled so i would be able to re-assemble.I contacted resmed on (b)(6) 2021 and told them about issue and that i did use a so-clean unit for cleaning.Their response was that they don't recommend third party cleaners and she would forward my issue to quality control.I have copd and have just made appointment (b)(6) for this years check up and plan on discussing this with my pulmonary physician then.My concerns are multiple with the main one being the size of the media that was inhaled over the course of the past 17 months.There is no recall on resmed units at this time.One picture is from online showing gasket/material.Second picture is what was left in my unit.Couldn't find model or catalog numbers.Fda safety report id# (b)(4).

• Brand Name: AIRCURVE 10 VAUTO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 12161064
• MDR Text Key: 261704374
• Report Number: MW5102510
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498370511
• UDI-Public: 00619498370511
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 1312242
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 76