MAUDE Adverse Event Report: SUNSET HEALTHCARE SOLUTIONS FILTER

Model Number CF1010

Device Problems Complete Blockage (1094); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

I have been using respironics dreamstation autocpap for approximately one year.When (b)(6), shipped ultrafine filters instead of ultrafine filters made by (b)(4), i started having problems where mean therapy pressure increased from approximately 9 to 15.I eventually determined that the pressure increase was due to the ultrafine filters becoming clogged.The generic filters are clogged after about 2 weeks of use; the respironics filters are not clogged after more than 4 weeks of use.The generic filters are supplied by (b)(4).

• Brand Name: FILTER
• Type of Device: FILTER
• Manufacturer (Section D): SUNSET HEALTHCARE SOLUTIONS; chicago IL
• MDR Report Key: 6442292
• MDR Text Key: 71251663
• Report Number: MW5068717
• Device Sequence Number: 2
• Product Code: CAH
• 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: 03/27/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CF1010
• Device Lot Number: 161007
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 102