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

Model Number DXS500T11W

Device Problem Insufficient Information (3190)

Patient Problems Asthma (1726); Dyspnea (1816); Cough (4457)

Event Date 07/07/2021

Event Type  Injury  

Event Description

Acute asthma; i had chest tightness, shortness of breath, congestion, a cough, and sinus congestion for about 10 days.Went to emergency room on (b)(6) 2021.Had an ekg.Was treated with a nebulizer, o2, and albuterol.Was prescribed prednisone and albuterol.It's now (b)(6) and i am still having breathing problems, although they are better then in early (b)(6).Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12276334
• MDR Text Key: 265261206
• Report Number: MW5102990
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959034129
• UDI-Public: 00606959034129
• 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: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DXS500T11W
• Device Catalogue Number: DSX500T11W
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 88