BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM B HEAT SOURCE

    MDR report key: 3290774 · Received August 15, 2013

    Report

    Report Number
    2016150-2013-00075
    Event Type
    Malfunction
    Date Received
    August 15, 2013
    Report Date
    July 26, 2013
    Manufacturer
    SYBRONENDO
    Product Code
    EAT
    PMA / PMN Number
    K970715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE SYSTEM B HEAT SOURCE DEVICE CONTINUED TO HEAT AFTER BEING UNPLUGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395384 SYSTEM B HEAT SOURCE PULP TESTER EAT SYBRONENDO 15-4751

    Patients

    Seq Age Sex Outcome Treatment
    1 Other