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

Model Number DREAMSTATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Fall (1848); Headache (1880); Vertigo (2134); Dizziness (2194); Unspecified Eye / Vision Problem (4471)

Event Date 05/15/2021

Event Type  Injury  

Event Description

Long lasting headaches, eye irritation, mild chest pain, imbalance, dizziness; headaches lasting for 35 minutes on top of head, slept well previous night but was very tired from noon till 5 pm, felt unsteady.Fell against walls at home, dizziness.Went to performance physical therapy for vertigo treatment.After 5-6 pt sessions vertigo problem resolved.Starting about (b)(6) 2021, headaches lasting longer-more intense continuous all day.I have an appointment at (b)(6) 2021.Manufactured date 11/24/2021.

• Brand Name: CPAP MACHINE DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 12075006
• MDR Text Key: 258892534
• Report Number: MW5102154
• 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: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/25/2023
• Device Model Number: DREAMSTATION
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 78 YR
• Patient Weight: 93