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 2017-11-08 for NOMAD PRO 0.850.0009 manufactured by Aribex.
[92517600]
The unit has not yet been returned to the manufacturer for an evaluation. If the unit is returned, an evaluation will be completed. A follow-up report will be submitted upon evaluation completion.
Patient Sequence No: 1, Text Type: N, H10
[92517601]
It was reported that there was a system error message. The batteries were changed, two images were taken, and the back of the device began to get hot to touch. There was no report of injury, patient or user involvement and no impact to patient care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2017-00065 |
| MDR Report Key | 7011380 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-08 |
| Date of Report | 2017-12-15 |
| Date of Event | 2017-10-10 |
| Date Mfgr Received | 2017-10-10 |
| Device Manufacturer Date | 2012-10-22 |
| Date Added to Maude | 2017-11-08 |
| 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 | DENTAL HYGIENIST |
| 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 | 2017-11-08 |
| Returned To Mfg | 2017-12-13 |
| Model Number | 0.850.0009 |
| Catalog Number | 0.850.0009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-11-08 |