MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for HONEYWELL HUMIDIFIER HWM 340B BLACK AND LIGHT GREY HWM340B manufactured by Kaz Usa, Inc., A Helen Of Troy Company.
[174660317]
I switched the unit's power switch to the off (center) position as we no longer needed to have the unit operating. After setting the switch to the off position, i noticed that the power indicator light was still illuminated. A couple of days later, i emptied the unit of remaining water as i had intended to simply replace it as i thought it had simply failed. When i tipped the unit up to pour the water out, it poured not only from the tank of the unit but also the base of the unit that contains the electronic controls. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092117 |
| MDR Report Key | 9569393 |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-11-17 |
| Date Added to Maude | 2020-01-09 |
| 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 |
| 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 | HONEYWELL HUMIDIFIER HWM 340B BLACK AND LIGHT GREY |
| Generic Name | HUMIDIFIER NON-DIRECT PATIENT INTERFACE |
| Product Code | KFZ |
| Date Received | 2020-01-08 |
| Model Number | HWM340B |
| Device Availability | N |
| 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 | 2020-01-08 |