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 2019-01-31 for NOMAD PRO 0.850.0009 manufactured by Aribex.
[135205125]
The unit was returned, and an evaluation was conducted. Upon visual inspection, it appears that a thermal event occurred. The thermal event caused significant melting of the handset such that a complete root cause analysis cannot be performed. It is not possible to determine the exact sequence of events that led to the thermal event. There is evidence that a short circuit occurred in the battery pack assembly. The lower battery pack of handset fused to handset printed circuit board and melted plastic due to expansion and heating of lower battery pack, which also fused the handset to the charger. No apparent heating of upper battery pack. This concludes the investigation.
Patient Sequence No: 1, Text Type: N, H10
[135205126]
It is reported that handset exploded while on the charging cradle. Damage to the counter top and other equipment in the office. There was no report of injury, patient or user involvement, or impact to patient care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2019-00003 |
| MDR Report Key | 8293507 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-30 |
| Date of Event | 2019-01-03 |
| Date Mfgr Received | 2019-01-03 |
| Device Manufacturer Date | 2010-01-26 |
| Date Added to Maude | 2019-01-31 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID WATERS |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877297 |
| 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 | 2019-01-31 |
| Returned To Mfg | 2019-01-15 |
| Model Number | 0.850.0009 |
| 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 | 2019-01-31 |