MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI BIONAIRE; HUMIDIFIER

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Consumer alleges her humidifier caught fire and caused smoke and floor damages to her bedroom.There was not a report of personal injury with this incident.

• Brand Name: BIONAIRE
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI; 2381 executive center dr.; boca raton FL 33431
• Manufacturer (Section G): DONGGUAN HUIXAN ELECTRICAL PRODUCTS CO.; no. 9112, hung yeh 8th road; tangxia town, ; CH
• Manufacturer Contact: michael miles ; 303 nelson ave.; neosho, MO 64850 ; 4174557441
• MDR Report Key: 7186203
• MDR Text Key: 97420667
• Report Number: 3003862163-2018-00010
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2018

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: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1