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 2019-03-18 for NOMAD PRO2 0.850.0021 FP 0150 manufactured by Airbex.
[139093173]
The device was returned for repair on (b)(6) 2019, with an evaluation being performed on (b)(6) 2019, based on the initial complaint of system failure. This initial evaluation identified a potential thermal event. Upon further visual inspection it appears that a thermal event occurred. It is not possible to determine the exact sequence of events that led to the thermal event. However, there is evidence that a short occurred in the upper battery pack between the cells and printed circuit board. There was a blackening on the top of the upper battery pack and its printed circuit board. 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
[139093174]
It was initially reported on (b)(6) 2019 that the device was giving a system failure message. There was no report of injuries, patient or user involvement, and no impact to patient care. The device was returned for repair and was received by the manufacturer on (b)(6) 2019. During an assessment by the repair department on (b)(6) 2019, a possible thermal event was identified on the handsets returned with the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2019-00007 |
| MDR Report Key | 8428530 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-18 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2015-10-29 |
| Date Added to Maude | 2019-03-18 |
| 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 | MR. DAVID WATERS |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877297 |
| Manufacturer G1 | AIRBEX |
| 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 PRO2 |
| Generic Name | EXTRAORAL SOURCE X-RAY SYSTEM |
| Product Code | EHD |
| Date Received | 2019-03-18 |
| Returned To Mfg | 2019-02-20 |
| Model Number | 0.850.0021 |
| Catalog Number | FP 0150 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIRBEX |
| Manufacturer Address | 11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-18 |