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

Model Number DSX500T11C

Device Problem Use of Device Problem (1670)

Patient Problems Dyspnea (1816); Fatigue (1849); Nausea (1970); Dizziness (2194); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Began using philips dreamstation cpap in 2018.Diagnosed with stage 5 kidney disease in (b)(6) 2019.Has breathing problems, fatigue, lightheadedness, shortness of breath and nausea as a result of cpap usage.

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 17282115
• MDR Text Key: 318658961
• Report Number: MW5119199
• 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: Unknown
• 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: DSX500T11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: APRESOLINE; ARANESP; ASPIRIN ; CARDURA; COREG; DEMADEX; FLONASE; KENALOG; NORVASC; OZEMPIC ; PRAVACHOL; PROTONIX; RANVELA; REVATIO; SILVADENE; ZYLOPRIM
• Patient Outcome(s): Disability; Required Intervention; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 128 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White