MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-23 for NOMAD PRO 2 0.850.0022 manufactured by Aribex.
[106258912]
The unit was returned and an evaluation was conducted. Upon visual inspection, it appears that a thermal event occurred. It is 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 upper battery pack between the cells and printed circuit board. There was a blackening on the top of the upper battery pack and its printed circuit board (pcb). Cells 5 and 6 appear 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. This concludes the investigation.
Patient Sequence No: 1, Text Type: N, H10
[106258913]
It was reported that the device and battery were smoking while not in use. There was no report of injuries, patient or user involvement and no impact to patient care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2018-00015 |
| MDR Report Key | 7452805 |
| Report Source | USER FACILITY |
| Date Received | 2018-04-23 |
| Date of Report | 2018-04-23 |
| Date of Event | 2018-03-29 |
| Date Mfgr Received | 2018-03-29 |
| Device Manufacturer Date | 2014-03-03 |
| Date Added to Maude | 2018-04-23 |
| 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. ERIKA MARTIN |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| 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 2 |
| Generic Name | EXTRAORAL SOURCE X-RAY SYSTEM |
| Product Code | EHD |
| Date Received | 2018-04-23 |
| Returned To Mfg | 2018-04-11 |
| Model Number | 0.850.0022 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-04-23 |