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

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

Patient Problems Arrhythmia (1721); Headache (1880); Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Event Description

Began using dream station cpap in 2017: chest pain; respiratory infection, headaches, irregular heartbeat/psv.

• Brand Name: DREAM STATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILLIPS/RESPIRONICS, INC.
• MDR Report Key: 17228497
• MDR Text Key: 318290801
• Report Number: MW5118966
• 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: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: PHILLIPS DREAMSTATION 2 ADVANCED.
• Patient Outcome(s): Required Intervention; Hospitalization; Disability
• Patient Age: 66 YR
• Patient Sex: Prefer Not To Disclose
• Patient Race: White