MAUDE Adverse Event Report: VICK'S - PROCTOR AND GAMBLE VICK'S; VICK'S FILTERFREE COOL MIST HUMIDIFIER

Model Number V4600 VICKS FILTERFREE HUMIDIFER

Device Problems Burst Container or Vessel (1074); Device Emits Odor (1425); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2016

Event Type  malfunction  

Event Description

I purchased a vick's humidifier last (b)(6) (less than a year ago) for use in my home.We use only filtered water with it and the tank is always kept full (never running while empty).However, despite how well we care for it, something distressing happened to it last week.My husband was at home with our newborn, and started smelling a burning smell.He followed the smell into the bedroom just in time to see smoke coming from the base/motor of the humidifier.It quite literally exploded.He unplugged it, and moved it out into our garage and made sure it wasn't going to start burning.Our entire house and garage smelled like burning plastic for three days.I am very upset about this, what if he had been napping with our child, and it had caught our house on fire while he was asleep? it is absolutely not okay for the motor on a humidifier to explode while in normal use.I contacted vick's (proctor and gamble) about my concerns, but was essentially told "oh too bad we can't help you, write to kaz instead", which i did.Retailer: (b)(6), retailer state: (b)(6).Purchase date: (b)(6) 2015, this date is an estimate.The product was not damaged before the incident.The product was not modified before the incident.Have you contacted the manufacturer? yes.I contacted vick's/p&g, and was told essentially "well we license these items to kaz, so you need to contact them because we can't help you." document number: (b)(4), report number: (b)(4).

• Brand Name: VICK'S
• Type of Device: VICK'S FILTERFREE COOL MIST HUMIDIFIER
• Manufacturer (Section D): VICK'S - PROCTOR AND GAMBLE
• MDR Report Key: 5578599
• MDR Text Key: 42771627
• Report Number: MW5061686
• Device Sequence Number: 1
• Product Code: KFZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V4600 VICKS FILTERFREE HUMIDIFER
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 MO