MAUDE Adverse Event Report: HOLMES; WARM MIST HUMIDIFIER

Model Number HWM6008

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Overheating of Device (1437)

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

Event Date 10/13/2016

Event Type  Other  

Event Description

Safety incident involved a bedroom humidifier.Humidifier was working fine for a complete winter season and into its second season.Two weeks ago i woke up in the middle of the night to the smell of burning plastic in the bedroom.I quickly realized that the awful smell was coming from the humidifier and immediately unplugged the unit.The smell in the room was so unpleasant, even with the windows open that i had to sleep in another room.The humidifier unit still smells burnt, although i can't actually see inside to know what was burnt.There was still some water in the humidifier unit when this incident occurred, but it was running pretty low and in need of a refill pretty soon.I have not used the humidifier since then and was going to call the mfr, but wanted to report to the cpsc first.Nobody was hurt in the incident, other than some lost sleep and irrupted breathing for a day.I now realize that i should have been pressing the "reset" button each time i loaded on a new tank, but the unit seemed to work without doing that.Still, that is no reason for the unit to burn itself up.Purchased at (b)(6)approx 1 year ago.Purchased date: (b)(6) 2015, this date is an estimate.I still have the humidifier and it still smells burnt.I will keep for 30 days in case you want it.I will contact the mfr after that.

• Brand Name: HOLMES
• Type of Device: WARM MIST HUMIDIFIER
• MDR Report Key: 6089594
• MDR Text Key: 59819427
• Report Number: MW5065927
• 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
• Type of Report: Initial
• Report Date: 10/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HWM6008
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR