MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-10-20 for NOMAD PRO 2 0.850.0021 manufactured by Aribex.
[90676036]
The unit has not been returned to the manufacturer for investigation, but it is anticipated that the user facility will return the unit. An evaluation will be performed once the unit is received and a follow-up report submitted upon evaluation completion.
Patient Sequence No: 1, Text Type: N, H10
[90676037]
It was reported that the batteries are hot to touch. There was no report of injuries, patient or user involvement, or impact to patient care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2017-00058 |
| MDR Report Key | 6965819 |
| Report Source | USER FACILITY |
| Date Received | 2017-10-20 |
| Date of Report | 2017-11-29 |
| Date of Event | 2017-09-22 |
| Date Mfgr Received | 2017-09-22 |
| Device Manufacturer Date | 2016-06-23 |
| Date Added to Maude | 2017-10-20 |
| 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 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 2 |
| Generic Name | EXTRAORAL SOURCE X-RAY SYSTEM |
| Product Code | EHD |
| Date Received | 2017-10-20 |
| Model Number | 0.850.0021 |
| Catalog Number | 0.850.0021 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-10-20 |