MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH 3M ESPE PENTAMIX 3 AUTOMATIC MIXING UNIT; AMALGAMATOR, DENTAL, AC-POWERED

Catalog Number 77876

Device Problem Electronic Property Issue (2928)

Patient Problem Electric Shock (2554)

Event Type  No Answer Provided  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: 3M ESPE PENTAMIX 3 AUTOMATIC MIXING UNIT
• Type of Device: AMALGAMATOR, DENTAL, AC-POWERED
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; seefeld ; GM
• Manufacturer Contact: carl-schurz-strasse 1; neuss 41453 ; 9815270013
• MDR Report Key: 4236985
• MDR Text Key: 5076357
• Report Number: 9611385-2014-00014
• Device Sequence Number: 1
• Product Code: EFD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 77876
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other