MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-04-24 for 3M TRUE DEFINITION SCANNER G7 78052 manufactured by 3m Espe Dental Products.
[73557666]
Electrical safety testing on the 3m true definition scanner, mobile edition was performed by 3m according to electrical safety standard iec (b)(4). The analysis found that the true definition mobile unit is operating within specification. An electrical evaluation of the dental operatory was conducted and one of the wall outlets in the operatory was found to be not properly grounded, but due to the type bf applied part this should have minimal effect on patient leakage current generated by the device. A nearby air conditioner unit was being serviced at the time, and the technician proposed that it could have interfered with the device. A more conclusive assessment of the site is needed to assess any impacts from the air conditioner unit. The incident occurred during a demonstration and the device is not at the site.
Patient Sequence No: 1, Text Type: N, H10
[73557667]
On (b)(6) 2017, 3m was notified that a 3m sales representative in (b)(6) experienced electrical sensations during a scanning demonstration using the 3m true definition scanner, mobile edition. No injury occured as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00036 |
| MDR Report Key | 6517540 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-24 |
| Date of Report | 2017-03-27 |
| Date Mfgr Received | 2017-03-27 |
| Device Manufacturer Date | 2016-12-27 |
| Date Added to Maude | 2017-04-24 |
| 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 | ANGIE DRAPER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| Manufacturer G1 | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 551441000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M TRUE DEFINITION SCANNER |
| Generic Name | SYSTEM,OPTICAL IMPRESSION, COMPUTER ASSISTED DESIGN AND MANUFACTURING (CAD/CAM) |
| Product Code | NOF |
| Date Received | 2017-04-24 |
| Model Number | G7 |
| Catalog Number | 78052 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | 2510 CONWAY AVENUE ST. PAUL MN 551441000 US 551441000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-24 |