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

Device Problem Material Discolored (1170)

Patient Problem Dyspnea (1816)

Event Date 11/20/2021

Event Type  malfunction  

Event Description

The filters are turning black and there is not sufficient air coming out to prevent me from not breathing correctly.Fda safety report id # (b)(4).

• Brand Name: PHILIPS DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 13087531
• MDR Text Key: 282896127
• Report Number: MW5106281
• 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: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2021
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CHOLESTEROL MEDS; DEPRESSION MEDS
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White