MAUDE Adverse Event Report: KAZ USA, INC. VICKS; HUMIDIFIER

Model Number V4450

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 05/16/2014

Event Type  Other  

Event Description

A consumer called and stated that their humidifier had stopped working.She stated that she used the humidifier to help relieve her son's allergies.Seven days after the humidifier broke, her son was admitted to the hospital with a collapsed lung.The consumer believes that this incident would not have occurred if the humidifier had been functioning properly.The intended use in the device's product labeling does not indicate that it is to be used as a therapeutic device for treating allergies.

• Brand Name: VICKS
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): KAZ USA, INC.; 250 turnpike road; southborough MA 01772
• Manufacturer Contact: sonja wilkinson ; 250 turnpike road; southborough, MA 01772 ; 5084907236
• MDR Report Key: 4037992
• MDR Text Key: 16545925
• Report Number: 1314800-2014-00066
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V4450
• Device Lot Number: 25610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 10 YR