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

Model Number SYSTEM ONE

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2021

Event Type  Injury  

Event Description

Found black foam particulates in the water tank of the cpap - respironics remstar plus, dom s/n (b)(4); system one htd humid, dom s/n (b)(4).Fda safety report id # (b)(4).

• Brand Name: CPAP PHILLIPS RESPIRONICS SYSTEM ONE HTD HUMID
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12280726
• MDR Text Key: 265407665
• Report Number: MW5103018
• 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: 08/03/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SYSTEM ONE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 57 YR
• Patient Weight: 76