BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDMARK

    MDR report key: 2954281 · Received January 9, 2013

    Report

    Report Number
    1523530-2013-00002
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 9, 2013
    Manufacturer
    MIDMARK CORP.
    Product Code
    EAZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHT WAS NOT RETURNED. PHOTOGRAPHIC EVIDENCE WAS GIVEN SHOWING THE CONNECTION POINTS. THE RESULTS ARE INCONCLUSIVE AS TO THE CAUSE. THERE ARE REDUNDANCIES BUILT INTO MAINTAINING THE LIGHT OVERHEAD. ONE THAT IT IS THREADED INTO A TROLLEY. IN THE TROLLEY THERE ARE 2 SET SCREWS THAT ARE SECURED INTO POSITION TO HOLD THE LIGHT IN PLACE. GIVEN THAT THE LIGHT WAS INSTALLED FOR 2 YEARS WITHOUT INCIDENT, THE LIKELY CAUSE IS IMPROPER INSTALLATION BY NOT TIGHTENING THE SET SCREWS. THE USER MANUAL CLEARLY STATES THAT THE SET SCREWS NEED TO BE TIGHTENED FOR PROPER INSTALLATION.

    Description of Event or Problem · 1

    THE LIGHT FELL. LIGHT LANDED ON THE DENTAL CHAIR. THERE WAS NO PT IN THE ROOM AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11495 MIDMARK LIGHT, OPERATING, DENTAL EAZ MIDMARK CORP. 18601

    Patients

    Seq Age Sex Outcome Treatment
    1