BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DCTM

    MDR report key: 1184181 · Received September 26, 2008

    Report

    Report Number
    1418964-2008-00001
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 26, 2008
    Manufacturer
    DEL MEDICAL IMAGING CORP.
    Product Code
    IYB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY INDICATIONS ARE THAT THE MALFUNCTION MAY HAVE BEEN DUE TO POOR MAINTENANCE. THE UNIT IS OUT OF SERVICE AND IS BEING RETURNED FOR EVALUATION, AND ANY ADDITIONAL RESULTS OR INFORMATION WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    COUNTER WEIGHT CABLE CAME LOOSE DUE TO WORN ANCHOR PIN IN COLUMN CAUSING COLUMNS TO DROP DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCTM X-RAY CEILING TUBE MOUNT IYB DEL MEDICAL IMAGING CORP. DCTM NA

    Patients

    Seq Age Sex Outcome Treatment
    1