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

Model Number "DSX500HJ1C"

Device Problem Use of Device Problem (1670)

Patient Problems Asthma (1726); Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Cancer (3262); Cough (4457); Epistaxis (4458); Unspecified Respiratory Problem (4464)

Event Date 01/01/2017

Event Type  Injury  

Event Description

Began using the dreamstation cpap (continuous positive airway pressure) (b)(6) 2017; sinus cancer, congestion, cough, nosebleeds, fatigue, asthma, tightness of chest and breathing difficulties.

• Brand Name: RESPIRONICS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 17217748
• MDR Text Key: 318111044
• Report Number: MW5118870
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: "DSX500HJ1C"
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALBUTERAL ; ATROVENT; COLACE; GABAPENTIN ; LASIX; LOSARTAN ; METFORMIN ; TOPROL-XL ; ZETRA
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 124 KG