MIRACLE MIST BREATHE EASY 17002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-05 for MIRACLE MIST BREATHE EASY 17002 manufactured by Ontel Products Corporation.

Event Text Entries

[141319954] Product is miracle mist breathe easy room humidifier bought at (b)(6) in 2017. Its model is 17002, ontel products corp, (b)(4). Made in (b)(4). The product functions as advertised. My problem is that it is not designed to have a wick (a filter) and even though i was using city water, the humidifier, i eventually discovered, was spewing out a white contaminate that was going through my home's duct work and clogging up the furnace filter, which in turn stopped the air flow causing the furnace to stop and cool down to about 62 degrees before coming back on. I spent about (b)(6) on 3 service calls before i discovered it was the filter and not the furnace. What is disturbing is that i was breathing in that contaminate from the air for several weeks before i discovered what was happening. I recommend that all vaporizers and humidifiers have wicks/filters so that water contaminates are not unsuspectingly being put out in our homes in the air that we breathe. Could be bad for people with asthma. Or at least warn people that tap water may be harmful to their health. I purchased in (b)(6) 2018. When i moved to different town i noticed problem. (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5085638
• MDR Report Key: 8491836
• Date Received: 2019-04-05
• Date of Report: 2019-02-20
• Date of Event: 2018-12-26
• Date Added to Maude: 2019-04-08
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: MIRACLE MIST BREATHE EASY
• Generic Name: HUMIDIFIER, NON-DIRECT PATIENT INTERFACE
• Product Code: KFZ
• Date Received: 2019-04-05
• Model Number: 17002
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ONTEL PRODUCTS CORPORATION
• Manufacturer Address: 21 LAW DRIVE FAIRFIELD NJ 07004 US 07004

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-04-05