MAUDE Adverse Event Report: HOLMES/ SUNBEAM PRODUCTS INC. WHITE HOLMES MODEL HWM6000 HUMIDIFIER; HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)

Device Problems Melted (1385); Smoking (1585)

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

Event Date 12/19/2017

Event Type  No Answer Provided  

Event Description

Holmes model hwm6000 humidifier degas smoking and plastic on the bottom of the unit began to melt, causing our smoke detectors to activate.Purchase date: (b)(6) 2015.

• Brand Name: WHITE HOLMES MODEL HWM6000 HUMIDIFIER
• Type of Device: HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)
• Manufacturer (Section D): HOLMES/ SUNBEAM PRODUCTS INC.
• MDR Report Key: 7453694
• MDR Text Key: 106589411
• Report Number: MW5076652
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1