MAUDE Adverse Event Report: RESMED CORP. RESMED AIRSENSE S10 CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number S10

Device Problems Degraded (1153); Particulates (1451)

Patient Problems Chest Pain (1776); Unspecified Respiratory Problem (4464)

Event Date 09/20/2022

Event Type  malfunction  

Event Description

Pt has been using a resmed airsense s10 since (b)(6) 2016.Pt reports about 3.5-4 yrs ago, developed chest pain, sob(shortness of breath), sinus issues, waking up coughing.Noted when looking inside device (not the water chamber/tube) that there was white dust, including in the form of spirals.When i first met him in (b)(6) 2022, i ordered a replacement device.Since starting replacement device, symptoms have been eliminated or reduced, leading pt to believe it may be due to degradation of interior components of prior machine.He did briefly use an external ozone cleaner (which did not pump through machine).Separately, reports also h/o gerd(history of gastroesophageal reflux disease), which is now resolved with new device, and sinus issues, not completely resolved.

• Brand Name: RESMED AIRSENSE S10 CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 16487289
• MDR Text Key: 310805363
• Report Number: MW5115430
• Device Sequence Number: 1
• 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: Physician
• Type of Report: Initial
• Report Date: 02/28/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: S10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White