MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-03-01 for NOMAD PRO 0.850.0009 manufactured by Aribex.
[101511143]
Upon visual inspection, it appeared that a thermal event occurred. It was not possible to determine the exact sequence of events that led to the thermal event. However, there is evidence that a short occured in the lower battery pack between the cells and printed circuit board. There was a blackening on the top of the lower battery pack and its printed circuit board. Cells 2 and 3 appeared to have been involved in the thermal event, likely by supplying energy into a fault in the board. Additionally there was a slight melting of the handset plastic enclosure. The unit was repaired and returned to customer. This concludes the investigation.
Patient Sequence No: 1, Text Type: N, H10
[101511144]
Customer returned unit to aribex for an annual evaluation. There was no report of injuries or impact to patient care. There was no indication of a product problem at the time of the initial report. The unit was evaluated on 02/08/2018 by a repair technician. During the evaluation, the technician determined that a battery handset required further investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2018-00007 |
| MDR Report Key | 7307061 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-01 |
| Date of Report | 2018-03-01 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-02-08 |
| Device Manufacturer Date | 2012-11-09 |
| Date Added to Maude | 2018-03-01 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ERIKA MARTIN |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877241 |
| Manufacturer G1 | ARIBEX |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOMAD PRO |
| Generic Name | EXTRAORAL SOURCE X-RAY SYSTEM |
| Product Code | EHD |
| Date Received | 2018-03-01 |
| Model Number | 0.850.0009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARIBEX |
| Manufacturer Address | 11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-01 |