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

Model Number DSX500H11C

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Headache (1880); Visual Disturbances (2140); Dizziness (2194)

Event Date 07/05/2021

Event Type  Injury  

Event Description

Ended in urgent care with acute bacterial sinusitis and severe headache.Fluid in the ears.Went to doctors 2 days in a row due to vision disturbance, headache and dizziness.Still having dizziness spells.Currently use a phillips dreamstation cpap machine.Fda safety report id # (b)(4).

• Brand Name: PHILLIPS DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILLIPS / RESPIRONICS, INC.
• MDR Report Key: 12203578
• MDR Text Key: 262975163
• Report Number: MW5102672
• Device Sequence Number: 1
• Product Code: BZD
• 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: 07/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500H11C
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 124