MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-10-31 for 3M ESPE PENTAMIX 3 AUTOMATIC MIXING UNIT 77876 manufactured by 3m Deutschland Gmbh.
[5076357]
The 3m espe was informed on (b)(6) 2014 that a dental office employee received an electrical shock after unplugging a 3m espe pentamix machine from a power outlet. It was reported that the employee was unplugging the machine to send it to the repair shop when she received the shock; no injury was sustained, no medical attention was sought, and the employee is currently fine.
Patient Sequence No: 1, Text Type: D, B5
[12601411]
The device was returned to the mfr and analyzed. It was found, that the device had a broken housing. Inside the machine a melted part was found. Potentially a short circuit caused overheating and melting. The cause of the broken housing couldn't be determined, but most likely improper handling or being dropped led to the damage. However, the analysis showed that it is unlikely that the broken housing is related to the event reported. The pentamix device is designed in a way that no electrically conducting parts are exposed to the device surface. The housing is made completely of plastics. The only parts made of metal exposed to the outside are the connectors and one small part of the driveshaft. These parts are grounded. So during intended use there's no possibility to get a life-threatening electrical shock by touching the outside of the device. As the user touched outside parts of the device and no conducting parts, it is not clear where the electrical shock came from. It can also be related to a static charge of the user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611385-2014-00014 |
| MDR Report Key | 4236985 |
| Report Source | 05 |
| Date Received | 2014-10-31 |
| Date of Report | 2014-09-11 |
| Date Mfgr Received | 2014-09-11 |
| Date Added to Maude | 2014-11-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | CARL-SCHURZ-STRASSE 1 |
| Manufacturer City | NEUSS 41453 |
| Manufacturer Country | GM |
| Manufacturer Postal | 41453 |
| Manufacturer Phone | 9815270013 |
| Manufacturer Street | ESPE PLATZ |
| Manufacturer City | SEEFELD |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M ESPE PENTAMIX 3 AUTOMATIC MIXING UNIT |
| Generic Name | AMALGAMATOR, DENTAL, AC-POWERED |
| Product Code | EFD |
| Date Received | 2014-10-31 |
| Returned To Mfg | 2014-09-18 |
| Catalog Number | 77876 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M DEUTSCHLAND GMBH |
| Manufacturer Address | SEEFELD GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-31 |