MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-19 for BLUEPHASE G2 100-240V 607920BE manufactured by Ivoclar Vivadent, Gmbh.
[98048426]
Patient Sequence No: 1, Text Type: N, H10
[98048427]
The equipment was not in use. The customer was charging the hand piece in the base when the battery burst and it became melted and charred. There was no damage to people or property (other than damage to the light itself). It is known that this event was caused by a failure in the old design battery cell. The plastic parts used for the casing are not flammable and performed as designed. They worked effectively to prevent a fire from occurring. Corrective action was undertaken in 2011. Batteries for the bluephase g2 with a date of manufacture up to and including april 2011 were replaced. The corrective action was for commercial non-safety reasons. Preventive action were taken in 2011. The following design improvements were made: nano-separators, protective foil and the removal of flash (protruding edge) inside the plastic battery housing. Batteries delivered since may 2011 include all improvements mentioned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000493628-2018-00001 |
| MDR Report Key | 7205948 |
| Date Received | 2018-01-19 |
| Date of Report | 2018-01-18 |
| Date of Event | 2017-11-30 |
| Date Facility Aware | 2017-12-19 |
| Date Mfgr Received | 2017-11-30 |
| Device Manufacturer Date | 2010-01-19 |
| Date Added to Maude | 2018-01-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SANDRA CAKEBREAD |
| Manufacturer Street | BENDERERSTASSE 2 |
| Manufacturer City | SCHAAN, FL-9494 |
| Manufacturer Country | LS |
| Manufacturer Postal | FL-9494 |
| Manufacturer Phone | 2353535 |
| Manufacturer G1 | IVOCLAR VIVADENT GMBH |
| Manufacturer Street | BRENSCHLSTRASSE 16 |
| Manufacturer City | BURS, A-6706 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | A-6706 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BLUEPHASE G2 |
| Generic Name | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION |
| Product Code | EBZ |
| Date Received | 2018-01-19 |
| Model Number | 100-240V |
| Catalog Number | 607920BE |
| Device Availability | N |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVOCLAR VIVADENT, GMBH |
| Manufacturer Address | BREMSCHLASTRASSE 16 BURS, A-6706 AU A-6706 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-19 |