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

Model Number CP2550-U

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

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

Event Type  malfunction  

Event Description

Consumer claims the humidifier smelled terrible like something was burning and she noticed smoke.There was no report of property damage with this incident.

• Brand Name: BIONAIRE
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC. DBA JARDEN CONSUMER SOLUTIONS; 2381 executive center dr.; boca raton FL
• Manufacturer (Section G): RAYMONDPANYU NANSHAELECTRICAL APPLIANCE DEVELOPMENT CO.LTD; 2 industrial road nansha district; guangzhou 0000 ; CN 0000
• Manufacturer Contact: tracie jones ; po box 2931; witchita, KS 67201-0000 ; 3162197325
• MDR Report Key: 4317220
• MDR Text Key: 5129563
• Report Number: 3006534621-2014-00132
• 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: 10/27/2014

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: CP2550-U
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/20/2014
• Initial Date FDA Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2003
• 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