MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-02 for VICTSING HUMIDIFIER USAS4-VTVTHM161AWUS-VD manufactured by Unknown.
[150378302]
We have been using this humidifier in my baby's nursery during the night, for sleep, and one day it stopped working and the light stayed red. I decided to test it out a couple times before trashing it. As i was testing it out one day, while i was in the nursery, and it began to spark. The sparking became fast and loud until luckily i was able to be there in time to unplug it. Thank god it wasn't during the night while my baby was sleeping a foot away from the humidifier. Victsing humidifier, order id: (b)(6) totaling (b)(6). Specifications: input: 100v-240v, 50-60 hz water tank capacity: 2. 0l max mist output: >180 ml/h? Product dimensions 10. 8 x 7. 5 x 10. 2 inches item weight 2. 45 pounds, shipping weight 2. 45 pounds (view shipping rates and policies) manufacturer victsing asin: (b)(6), item model number: usas4-vtvthm161awus-vd. Retailer: (b)(6). Retailer state: (b)(6). Purchase date: (b)(6) ''219''. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5087882 |
| MDR Report Key | 8760708 |
| Date Received | 2019-07-02 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-05-01 |
| Date Added to Maude | 2019-07-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | VICTSING HUMIDIFIER |
| Generic Name | HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE) |
| Product Code | KFZ |
| Date Received | 2019-07-02 |
| Model Number | USAS4-VTVTHM161AWUS-VD |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-02 |