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

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2020

Event Type  malfunction  

Event Description

With normal use with a new (received less than 6 weeks ago) humidifier chamber, part of the bottom edge of the plastic top of the chamber broke off when closing after refilling.Thus the chamber no longer seals and now holds only a minimal amount of water without leaking, particularly when carrying or inserting the chamber into the device.This means the humidifier is nearly useless.Fda safety report id # (b)(4).

• Brand Name: AIRSENSE 10
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 10257478
• MDR Text Key: 198568305
• Report Number: MW5095468
• 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: Patient
• Type of Report: Initial
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 95