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

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Headache (1880); Sore Throat (2396); Foreign Body In Patient (2687); Cough (4457)

Event Date 07/27/2021

Event Type  Injury  

Event Description

I had cough and congestion with no fever, headache, sore throat or shortness of breath.The cough and congestion have been persisted for more than 3 months.I had been taking multiple course of antibiotic to no avail.I had occasionally saw something black in my mouth.The result has not been provided.Fda safety report id # (b)(4).

• Brand Name: CPAP BRAND PHILLIPS RESPIRONIC DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12480846
• MDR Text Key: 272029127
• Report Number: MW5103977
• Device Sequence Number: 1
• Product Code: BZD
• 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: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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): Disability
• Patient Age: 75 YR
• Patient Weight: 106