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

Model Number DSX500H11C

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Asthma (1726); Pain (1994); Numbness (2415); Taste Disorder (4422); Cough (4457); Unspecified Kidney or Urinary Problem (4503)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Began using philips dreamstation cpap in (b)(6) 2017.Suffers from asthma, chronic cough, kidney stones, joint pain, extremity numbness, strange taste in mouth.

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 17282213
• MDR Text Key: 318663263
• Report Number: MW5119201
• 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: DSX500H11C
• Patient Sequence Number: 1
• Treatment: ALOPURINOL ; ALPRAZOLAM; BETAMETHAZONE; BUSPIRONE; CELEBREX; FLUTICASONE PROPIONATE; LEVALBUTEROL ; LISINOPRIL ; MONTELUKAST; OMEPRAZOLE; PREDNISONE ; TADALAFIL
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White