MAUDE Adverse Event Report: PHILLIPS RESPIRONICS, INC. PHILLIPS DREAMSTATION 1; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Insufficient Information (3190)

Patient Problems Pneumonia (2011); Unspecified Kidney or Urinary Problem (4503)

Event Type  Injury  

Event Description

Restronic phillips dreamstation 1.I have developed chronic kidney disease stage 3, pneumonia last 6 months, spots on lungs last 2 years.Fda safety report id# (b)(4).

• Brand Name: PHILLIPS DREAMSTATION 1
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILLIPS RESPIRONICS, INC.
• MDR Report Key: 12130086
• MDR Text Key: 260499432
• Report Number: MW5102316
• 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: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• 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 Weight: 72