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

Model Number DSX500H11C

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pneumonia (2011); Sore Throat (2396); Cough (4457); Unspecified Respiratory Problem (4464)

Event Type  Death  

Event Description

Was using philips respironics dreamstation cpap.Developed respiratory tract problems, cough, runny nose, throat irritation which caused swallowing problems and lead to issues of aspiration pneumonia and dysphagia.Doctors were unable to diagnose cause or problems and since it was a recurring issue that doctors were unable to effectively treat, patient passed away.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION NONCONTINUOUS VENTILATOR
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12860895
• MDR Text Key: 281199728
• Report Number: MW5105506
• 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: No Information
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: DSX500H11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Death; Disability
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White