VICKS HUMIDIFIER V750D1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for VICKS HUMIDIFIER V750D1 manufactured by Kaz Usa, Inc.

Event Text Entries

[138083795] Caller stated that the humidifier started smoking about 6 hours later after it was turned off. She stated that her daughter alerted her that there was a burning odor and then she noticed the smoke; the unit had overheated. Caller stated that the unit was unplugged and even at that time steam was emitting from the core of it. The manufacturer was contacted and they advised her to return it for a replacement; however, she does not feel they are concerned about the fire hazard it presents. Caller feels that this humidifier is unsafe and should be reported. Retailer: (b)(6). Purchase date: (b)(6) 2016. This date is an estimate. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5084694
MDR Report Key8396422
Date Received2019-03-06
Date of Report2019-01-17
Date of Event2019-01-15
Date Added to Maude2019-03-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVICKS HUMIDIFIER
Generic NameHUMIDIFIER, NON-DIRECT PATIENT INTERFACE
Product CodeKFZ
Date Received2019-03-06
Model NumberV750D1
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerKAZ USA, INC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.