MAUDE Adverse Event Report: PHILLIPS HUMIDIFIER

Device Problems Thermal Decomposition of Device (1071); Corroded (1131); Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2014

Event Type  malfunction  

Event Description

Phillips responics model 550p sn: (b)(4), humidifier sn: (b)(4).The tech i talked to at apiria heath care said the flashing light meant the unit failed and would not heat well.I have no heat and i am attaching a video for you to see it flashing.Anything you can do to help me is appreciated.Thank you.I opened the unit and found a burnt connection that made the unit fail.I have pictures of the burnt location it was on the hot lead that powers the heater unit part of the equipment.I think this is a design fail due to 2 different metals, due to corrosion made over time.I sent pictures to phillips: (b)(4).

• Brand Name: HUMIDIFIER
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): PHILLIPS
• MDR Report Key: 4652144
• MDR Text Key: 5683233
• Report Number: MW5041779
• 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: 03/27/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR