MAUDE Adverse Event Report: JARDEN CONSUMER SOLUTIONS, DBA, SUNBEAM PRODUCTS BIONAIRE; HUMIDIFIER

Model Number BWM2601

Device Problems Break (1069); Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Consumer alleges his humidifier burned through the bottom and damaged his flooring.No injuries were reported with this incident.

Manufacturer Narrative

Abuse by the consumer from failure to take preventative action to properly clean the humidifier caused this failure.

• Brand Name: BIONAIRE
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): JARDEN CONSUMER SOLUTIONS, DBA, SUNBEAM PRODUCTS; executive ctr dr; boca raton FL
• Manufacturer (Section G): DONGGUAN HUIXAN ELECTRICAL PRODUCTS CO.LTD; no.9112, hung yeh 8th road; tangxia town,dongguan ; CH
• Manufacturer Contact: tracie jones ; p.o. box 2931; wichita, KS 67201 ; 3162197325
• MDR Report Key: 3820686
• MDR Text Key: 22265785
• Report Number: 3003862163-2014-00079
• 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: Unknown
• Type of Report: Initial
• Report Date: 05/02/2014

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
• Device Model Number: BWM2601
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/02/2014
• Initial Date Manufacturer Received: 04/02/2014
• Initial Date FDA Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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