BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RITTER

    MDR report key: 4281453 · Received November 21, 2014

    Report

    Report Number
    1523530-2014-00016
    Event Type
    Malfunction
    Date Received
    November 21, 2014
    Date of Event
    October 21, 2014
    Report Date
    November 20, 2014
    Manufacturer
    MIDMARK CORP.
    Product Code
    EAZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOGRAPHIC EVIDENCE WAS EVALUATED AND SHOWED THAT COMPONENTS OF THE MIDMARK 355 LIGHT WERE MODIFIED BY SOMEONE OTHER THAN MIDMARK. IT IS UNK IF THIS ADULTERATION CONTRIBUTED TO THE FAILURE. ADDITIONAL TESTING WAS PERFORMED ON A SIMILAR MIDMARK 355 LIGHT AND FOUND NO FAILURE WOULD OCCUR WITH NORMAL USE AND PREVENTATIVE MAINTENANCE. NOTIFICATION WAS GIVEN TO THE CUSTOMER ON WHAT NORMAL USE AND PREVENTATIVE MAINTENANCE IS REQUIRED FOR THIS DEVICE.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT MIDMARK 355 LIGHT HAD (4) MOUNTING SCREWS SHEAR AND THE LIGHT FELL FROM ITS CEILING MOUNTING. NO INJURIES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758042 RITTER PROCEDURE LIGHT EAZ MIDMARK CORP. 355-028

    Patients

    Seq Age Sex Outcome Treatment
    1