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

Model Number DSX500T11

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arrhythmia (1721); Sore Throat (2396)

Event Type  Injury  

Event Description

Began using philips dreamstation cpap (b)(6) 2018.Has irregular heartbeat, chronic laryngitis, chronic sinus problems and inflammation as a result of cpap usage.

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS
• MDR Report Key: 17282042
• MDR Text Key: 318655526
• Report Number: MW5119197
• 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: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: EYE DROPS
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White