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 C-12 manufactured by Tobii Electronics Technology Suzhou Co., Ltd..
[3661094]
Wheelchair power adapter shorted out and melted. Fuse blew but there still appeared to be additional damage to wire. I asked (b)(6) to call in to tech support about it and to send us photos and/or the item for analysis. C12 does not appear to be damaged, no injuries, just concern about safety of this item.
Patient Sequence No: 1, Text Type: D, B5
[10983884]
A unit was reported faulty in the field and returned to us - upon closer inspection, it seems as if a short circuit occurred. The reason is likely due to improper third party installation, resulting in a grounding fault between the wheelchair chassis and the wheelchair battery. Under this circumstance, and in the case of a short circuit, there is a risk of a heat rush which could cause a fire. We feel that the consequences could have been significant enough that we have made the decision to implement additional safety measures to the design, and retroactively fit all units in the field at no charge to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007873415-2013-00002 |
| MDR Report Key | 3253582 |
| Report Source | 99 |
| Date Received | 2013-06-03 |
| Date of Report | 2013-05-14 |
| Date of Event | 2012-01-26 |
| Date Mfgr Received | 2012-01-27 |
| Device Manufacturer Date | 2011-02-01 |
| 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 | C-12 |
| Product Code | ILQ |
| Date Received | 2013-06-03 |
| Model Number | C-12 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOBII ELECTRONICS TECHNOLOGY SUZHOU CO., LTD. |
| Manufacturer Address | NO. 678, FENGTING AVE. LAND INDUSTRIAL PARK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-03 |