MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-22 for NARROW BAND UVB SPECTRA 311 * manufactured by Darvlin.
[587223]
Pt in phototherapy booth for treatment. Unit did not shut off at end of treatment. Main electrical switch shut off. There are 3 relay switches. One was found to be stuck in the "on" position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042030 |
| MDR Report Key | 821235 |
| Date Received | 2007-02-22 |
| Date of Report | 2007-02-15 |
| Date of Event | 2006-11-16 |
| Date Added to Maude | 2007-03-01 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NARROW BAND UVB |
| Generic Name | * |
| Product Code | KGL |
| Date Received | 2007-02-22 |
| Model Number | SPECTRA 311 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 808663 |
| Manufacturer | DARVLIN |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-22 |