MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-24 for SUNDASH RADIUS SR -48 * manufactured by *.
[5709188]
I am a fire investigator. I recently responded to a fire involving a sundash radius st-48. The fire was contained to the electrical cord that connects the main unit to the door. This appears to be a design flaw. The bundle of electrical wires contained in the protective sleeve hid arching wire from immediate observation and detection. This arch heated and eventually flamed up while in use by a customer. The fire was extinguished with a dry chemical extinguisher. The design flaw is the hinge has a sharp bend in the electrical bundle. The more the door is opened and closed the more the potential for the wiring insulation to break down. (b)(6) is the place of business. Place of recreation or sports - (b)(6). Investigators: (b)(6) fire incident # (b)(6). Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042288 |
| MDR Report Key | 4730457 |
| Date Received | 2015-04-24 |
| Date of Event | 2015-03-23 |
| Date Added to Maude | 2015-04-27 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUNDASH RADIUS SR -48 |
| Generic Name | STAND UP SUN TAN BOOTH |
| Product Code | LEJ |
| Date Received | 2015-04-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-24 |