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.
[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
| Report Number | MW5084694 |
| MDR Report Key | 8396422 |
| Date Received | 2019-03-06 |
| Date of Report | 2019-01-17 |
| Date of Event | 2019-01-15 |
| Date Added to Maude | 2019-03-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VICKS HUMIDIFIER |
| Generic Name | HUMIDIFIER, NON-DIRECT PATIENT INTERFACE |
| Product Code | KFZ |
| Date Received | 2019-03-06 |
| Model Number | V750D1 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAZ USA, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-06 |