MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-13 for 3M TRUE DEFINITION SCANNER WAND G6 75030 manufactured by .
[18894562]
During a scanning procedure using a 3m true definition scanner, a patient experienced a shock inside her mouth and on her arm where it touched the dental chair. The individual performing the scan did not feel a shock. Upon investigation, it was learned that the true definition scanner was performing as intended and stray voltage was not identified. It was determined that not only was the ground in the outlet into which the scanner had been plugged intermittently failing, but also that the 30+ year old electric dental chair was not properly grounded. Voltages on the chair of 112v were measured. When the true definition scanning wand was placed into the patient's mouth, it allowed for a discharge of the energy to ground, resulting in the shock. The dentist has been advised of and agrees with the findings of the investigation that the chair was the cause of the shocks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2015-00028 |
| MDR Report Key | 4686997 |
| Report Source | 05 |
| Date Received | 2015-04-13 |
| Date of Report | 2015-04-01 |
| Date of Event | 2015-03-27 |
| Date Mfgr Received | 2015-04-01 |
| Date Added to Maude | 2015-04-15 |
| 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 | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | SAINT PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M TRUE DEFINITION SCANNER WAND |
| Generic Name | SYSTEM, OPTICAL IMPRESSION |
| Product Code | NOF |
| Date Received | 2015-04-13 |
| Model Number | G6 |
| Catalog Number | 75030 |
| Lot Number | S1451028 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-13 |