MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-09-12 for NOMAD PRO 2 0.850.0021 manufactured by Aribex.
[120105426]
The unit was returned and an engineering evaluation completed. Visual inspection shows signs of electrolyte leakage on the tube head plastic enclosure and a thermal event in lower battery pack. 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 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 (pcb). Cells 2 and 3 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
[120105427]
It was reported that the unit was leaking a substance. The device had not been dropped. There was no report of patient or user injury, no patient or user involvement, and no impact to patient care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2018-00026 |
| MDR Report Key | 7870400 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-12 |
| Date of Report | 2018-09-12 |
| Date of Event | 2018-08-14 |
| Date Mfgr Received | 2018-08-14 |
| Device Manufacturer Date | 2014-02-12 |
| Date Added to Maude | 2018-09-12 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-09-12 |
| Returned To Mfg | 2018-08-31 |
| Model Number | 0.850.0021 |
| Catalog Number | 0.850.0021 |
| 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 | 2018-09-12 |