MAUDE Adverse Event Report: PHILLIPS RESPIRONICS SYSTEM ONE W/HUMIDIFIER

Model Number 638E

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 02/19/2014

Event Type  Injury  

Event Description

I use a phillips respironics system one cpap machine.It needs its humidifier to keep the air warm enough to breathe and moist enough to keep from totally dehydrating your airway.Unfortunately, the humidifier only holds 3 hrs to 4 hrs of water.Once it runs out the heating element pumps noxious fumes into your lungs for the rest of the night.It should shut off when it runs out of water and not superheat the air or give off the fumes which are noxious.The lack of sufficient water defeats the purpose of having a device intended to help you sleep all night.

• Brand Name: SYSTEM ONE W/HUMIDIFIER
• Type of Device: SYSTEM ONE W/HUMIDIFIER
• Manufacturer (Section D): PHILLIPS RESPIRONICS
• MDR Report Key: 3647222
• MDR Text Key: 18300387
• Report Number: MW5034713
• Device Sequence Number: 2
• Product Code: BTT
• 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: 02/20/2014
• 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: 638E
• Other Device ID Number: HUMIDIFIER: H09821602 638E
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 116