MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-02 for SUNBEAM SERIES 001388-800 WARM MIST VAPORIZER manufactured by Jarden Consumer Solutions / Sunbeam Products, Inc..
[144182344]
I have used this model vaporizer for two years. However, i was never aware of its scalding potential. The device runs next to my bed: approx 1. 5 to 2 feet from me. One night last week, my arm decided to flop out of bed during sleep and the lower part of my arm came to rest on the humidifier. I soon awoke in great pain. The device had scaled me severely. There are no warnings about scalding on the box or in the instructions. Only regarding electrical hazards. There is a small print "caution" on the device itself that warns about "mist can be hot. Keep from children". It does not warn of scalding or tells the user to keep several feet away from bedside. In fact, the box is somewhat misleading. It states the mist is "warm and soothing". This device is mfg differently than vicks. The sunbeam steam exhaust vents actually rise. The vicks model has its steam vent recessed. Retailer: (b)(6); retailer state: online. Purchase date: (b)(6) 2019. Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086366 |
| MDR Report Key | 8577931 |
| Date Received | 2019-05-02 |
| Date of Report | 2019-04-09 |
| Date of Event | 2019-04-03 |
| Date Added to Maude | 2019-05-03 |
| 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 |
| 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 | SUNBEAM SERIES 001388-800 WARM MIST VAPORIZER |
| Generic Name | HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME USE) |
| Product Code | KFZ |
| Date Received | 2019-05-02 |
| Model Number | 001388-800 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JARDEN CONSUMER SOLUTIONS / SUNBEAM PRODUCTS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-02 |