MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-06-03 for TOBII P-10 501052 manufactured by Tobii Technology Ab Karlsrovagen 2d.
[21661187]
Dc/dc converter output ground cable caught fire. The cause was short circuit that we believe to be related to an improper 3rd party installation. To prevent this in the future, a fuse now prevents a dangerous situation in the event of a short circuit. It appears that the ground wire from the dc/dc converter (victron energy sn (b)(4). Input18-35v/output 13. 8v 5a max) had compromised insulation from the original installation. If the damaged insulation allowed the bare ground wire to short circuit to the battery terminal, this would cause the fire. The damage is limited to the ground conductor of a two conductor wire that was split and wrapped with electrical tape.
Patient Sequence No: 1, Text Type: D, B5
[21891459]
It appears that the ground wire from the dc/dc converter (victron energy sn (b)(4). Input18-35v/output 13. 8v 5a max) had compromised insulation from the original installation. If the damaged insulation allowed the bare ground wire to short circuit to the battery terminal, this would cause the fire. The damage is limited to the ground conductor of a two conductor wire that was split and wrapped with electrical tape.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007873415-2013-00001 |
| MDR Report Key | 3253583 |
| Report Source | 99 |
| Date Received | 2013-06-03 |
| Date of Report | 2013-05-14 |
| Date of Event | 2011-08-01 |
| Date Mfgr Received | 2011-08-01 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2013-08-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LYLE SHERWOOD |
| Manufacturer Street | 333 ELM STREET |
| Manufacturer City | DEDHAM MA 02026 |
| Manufacturer Country | US |
| Manufacturer Postal | 02026 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOBII |
| Generic Name | TOBII P-10 |
| Product Code | ILQ |
| Date Received | 2013-06-03 |
| Model Number | P-10 |
| Catalog Number | 501052 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOBII TECHNOLOGY AB KARLSROVAGEN 2D |
| Manufacturer Address | DANDERYD SE18253P SW SE18253P- |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-03 |