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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/08/2021

Event Type  malfunction  

Event Description

I was issued a philips dreamstation cpap by the (b)(6) medical center in (b)(6)2020.I have been using it nightly for the last 1.5yrs.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12985486
• MDR Text Key: 282266180
• Report Number: MW5105992
• 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: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALBUTEROL INHALER ; ZYRTEC
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White