MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. RESPIRONICS--SYSTEM ONE; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number 560P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Severe and recurring sinus infections requiring medication and irrigation.Fda safety report id # (b)(4).

• Brand Name: RESPIRONICS--SYSTEM ONE
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12633108
• MDR Text Key: 276674784
• Report Number: MW5104593
• Device Sequence Number: 1
• Product Code: MNS
• 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: 10/08/2021

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 Operator: Lay User/Patient
• Device Model Number: 560P
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 136