MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for 2100-WGN manufactured by Kaz Usa, Inc. A Helen Of Troy Company.
[176668464]
The consumer indicates that she woke up at 0300 hours to the smell of burning and noises of pop and sparking. The consumer turned on her light and it immediately started flashing so she turned off and unplugged the dialysis machine and its modem as well as a vaporizer connected to a surge protector. The vaporizer notes that the vaporizer was spraying water out of it instead of steam. The consumer notes that when she dumped the water from her vaporizer, black chunks were also in the water. The consumer states that the unit was used only twice for approximately four hours each use. The consumer plans on keeping her vaporizer for at least the next thirty days. (b)(6). Purchase date: (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092498 |
| MDR Report Key | 9632037 |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-24 |
| Date of Event | 2019-12-07 |
| Date Added to Maude | 2020-01-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | UNKNOWN |
| 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 | 3 |
| Brand Name | 2100-WGN |
| Generic Name | HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME USE) |
| Product Code | KFZ |
| Date Received | 2020-01-24 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAZ USA, INC. A HELEN OF TROY COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |