MAUDE Adverse Event Report: RESMED CORP. RESMED AIRSENSE 10 CPAP AUTO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 37208

Device Problems Particulates (1451); Material Separation (1562)

Patient Problem Respiratory Tract Infection (2420)

Event Date 10/12/2021

Event Type  malfunction  

Event Description

Little green pieces of foam in water chamber after usage and pt brought to dme when this happened.(b)(6) the owner tried contacting resmed several times to discuss and has not returned our phone call to date.Pt reported she is experiencing an upper respiratory infection since incident but is not sure it is due to device.(b)(6) a repair tech from our sister company took off motor area and seen that the green filter was falling apart inside the unit.Pt was using a soclean device with this device.

• Brand Name: RESMED AIRSENSE 10 CPAP AUTO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP. ; san diego CA
• MDR Report Key: 12682265
• MDR Text Key: 278358663
• Report Number: MW5104885
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 37208
• Device Catalogue Number: 37208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 63