BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXISKY 600

    MDR report key: 2110963 · Received March 28, 2011

    Report

    Report Number
    9681684-2011-00025
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BHM MEDICAL INC.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO WILL BE PROVIDED UPON MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    UPON INSPECTION OF TRACKS INSTALLATION AFTER CUSTOMER COMPLAINT, IT WAS REPORTED BY THE ENGINEER THAT THE UNISTRUT IN LOFT WERE NOT SCREWED DOWN TO JOINTS CORRECTLY OR NOT SCREWED DOWN AND WERE LOOSE. THERE WAS NO PT INVOLVED AND NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXISKY 600 MANUFACTURED CEILING FIXED CASSETTES FNG BHM MEDICAL INC. LD10005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other