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 2018-06-22 for NOMAD PRO HANDHELD X-RAY SYSTEM 0.850.0009 manufactured by Aribex.
[112474314]
The unit was returned and an initial evaluation was conducted. It was determined the unit may be emitting radiation while the power is on, but further investigation is needed. No conclusions have been made as the evaluation is ongoing. A follow-up report will be submitted after the completion of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[112474315]
It was reported that the unit is not powering down and the battery must be removed to power off. The radiation lights turn orange as if the device is taking exposures on its own. There was no report of injuries, patient or user involvement ot impact to patient care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2018-00020 |
| MDR Report Key | 7630291 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-22 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-05-24 |
| Date Mfgr Received | 2018-05-24 |
| Device Manufacturer Date | 2008-08-19 |
| Date Added to Maude | 2018-06-22 |
| 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 |
| 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 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 HANDHELD X-RAY SYSTEM |
| Generic Name | EXTRAORAL SOURCE X-RAY SYSTEM |
| Product Code | EHD |
| Date Received | 2018-06-22 |
| Returned To Mfg | 2018-06-08 |
| 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 | 2018-06-22 |