BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RITTER

    MDR report key: 2456419 · Received January 27, 2012

    Report

    Report Number
    1523530-2012-00002
    Event Type
    Malfunction
    Date Received
    January 27, 2012
    Date of Event
    December 28, 2011
    Report Date
    January 26, 2012
    Manufacturer
    MIDMARK CORPORATION
    Product Code
    KZF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOGRAPHS OF THE DEVICE WERE EXAMINED. THE TYPE OF BREAKAGE OBSERVED INDICATED THAT THE SCREWS HOLDING THE FACEPLATE ONTO THE LIGHT HEAD WERE OVER TIGHTENED CAUSING THE FACE PLATE TO FRACTURE AROUND THE SCREW HEAD. THERE WERE WASHERS PLACED BETWEEN THE SCREW HEAD AND THE FACEPLATE WHICH WERE NOT PART OF THE ORIGINAL ASSEMBLY. IT WAS APPARENT THAT THE FACEPLATE HAD BEEN REMOVED AND REINSTALLED. IMPROPER DEVICE MAINTENANCE CAUSED THE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHT FACEPLATE AND HANDLE ASSEMBLY FELL ONTO A PT. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RITTER PROCEDURE LIGHT KZF MIDMARK CORPORATION 355-025

    Patients

    Seq Age Sex Outcome Treatment
    1