MAUDE Adverse Event Report: WACHSMUTH AND KROGMANN INC./DISTRIBUTED BY ALDI IMPORTER CROFTON; WARM MIST HUMIDIFIER

Model Number EE-5200B

Device Problems Device Emits Odor (1425); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2014

Event Type  Other  

Event Description

Our crofton warm mist humidifier item #1768-12/model#ee-5200b that is approximately 2 years old was about 1/2 full of water and plugged in and set to 1 for the night in my (b)(6) son's bedroom.The unit was placed on the carpet and should not have been.I forgot this since i only recently began using it again.At 3:40am all of our smoke alarms in the house began going off.Thankfully they are all wired together and there is one in my son's bedroom! if this hadn't been the case the outcome could have very easily been much worse.My son emerged from his bedroom and there was a lot of smoke coming from his room.It smelled of burnt plastic.It was very close to bursting into flames.My husband quickly unplugged the humidifier and carried the smoking unit outside.He did receive a small burn on his hand that he treated himself.The humidifier did leave some burnt plastic stuck to the rug.The bottom of the unit is very melted.It took days to clean and deodorize everything in his room.I have contacted (b)(4) and they are sending me a box to send the unit back to them.They are very anxious to study the unit but i would like to hear from you that it is okay to send it to them.Incident, no injury.Purchase date: (b)(6) 2012 this date is an estimate.I still have the product in my possession.Yes.The product was damaged before the: no.Explanation: contacted (b)(4), (b)(6) from customer service very anxious for me to ship product to them.This is a copy of your report to the u.S.Consumer product safety commission submitted on 11/07/2014.Document number: (b)(6).Report number: (b)(4).

• Brand Name: CROFTON
• Type of Device: WARM MIST HUMIDIFIER
• Manufacturer (Section D): WACHSMUTH AND KROGMANN INC./DISTRIBUTED BY ALDI IMPORTER
• MDR Report Key: 4908609
• MDR Text Key: 6538717
• Report Number: MW5043982
• 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

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?: No
• Device Operator: Other
• Device Model Number: EE-5200B
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2015
• Patient Sequence Number: 1
• Patient Age: 45 YR