BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OR BOOM, MMP200, 750MM SH

    MDR report key: 2990986 · Received March 6, 2013

    Report

    Report Number
    0002031963-2013-00012
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    STRYKER-COMMUNICATIONS
    Product Code
    BRY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE END CAP COVER OF AN EQUIPMENT BOOM ALLEGEDLY FELL OFF DURING ROOM PREPARATION BEFORE A SURGERY. IT COULD NOT BE DETERMINED EXACTLY HOW THE COVER DETACHED AND FELL, BUT IT'S LIKELY THAT IT WAS IMPACTED BY ANOTHER PIECE OF EQUIPMENT DAMAGING THE COVER AND CAUSING IT TO BECOME LOOSE AND FALL. THERE WAS NO PATIENT INVOLVEMENT AS IT OCCURRED PRIOR TO A PROCEDURE AND NO ADVERSE CONSEQUENCES WERE REPORTED. THE END CAP WAS REPLACED AND THE BOOM WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UPPER ARM END CAP OF AN ARTICULATING EQUIPMENT BOOM IN OR14 ALLEGEDLY FELL OFF OF THE BOOM DURING ROOM PREPARATION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95537 OR BOOM, MMP200, 750MM SH EDS BOOMS BRY STRYKER-COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1