BEUDAMED
    FDA Adverse Event Summary report: N

    3M ESPE PENTAMIX 3 AUTOMATIC MIXING UNIT

    MDR report key: 4236985 · Received October 31, 2014

    Report

    Report Number
    9611385-2014-00014
    Date Received
    October 31, 2014
    Report Date
    September 11, 2014
    Manufacturer
    3M DEUTSCHLAND GMBH
    Product Code
    EFD
    PMA / PMN Number
    K991913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698231 3M ESPE PENTAMIX 3 AUTOMATIC MIXING UNIT AMALGAMATOR, DENTAL, AC-POWERED EFD 3M DEUTSCHLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other