MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. DREAMSTATIOIN AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Nonstandard Device (1420); Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 11/27/2021

Event Type  malfunction  

Event Description

Cpap used on prescription regular basis, machine is under "use" at own risk recall.How can i tell.No specific information given relative to cause/problem relationship.Only see abnormal machine residue in water container.Can something else be cause of red residue to eliminate concern? i have a picture of container with residue and result appears to occur "ofter" enough to produce again for lab testing.This report references report mw5107379.

• Brand Name: DREAMSTATIOIN AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13507462
• MDR Text Key: 285529816
• Report Number: MW5107378
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Type of Device Usage: A
• Patient Sequence Number: 1