BEUDAMED
    FDA Adverse Event Other Summary report: N

    SH 750MM 6GAS 8ELEC SHELVES

    MDR report key: 1616825 · Received February 5, 2010

    Report

    Report Number
    2031963-2010-00037
    Event Type
    Other
    Date Received
    February 5, 2010
    Date of Event
    January 8, 2010
    Report Date
    January 8, 2010
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT, THUS NO PT DATA EXISTS. THERE IS NO ESTABLISHED EXPIRATION DATE FOR THE SAID DEVICE. DEVICE WAS EVALUATED IN THE FIELD ON JANUARY 7TH 2010. EVAL SUMMARY: THE INVESTIGATION CONFIRMED THAT THIS ISSUE IS RELATED TO INSTALLATION AND SERVICING. THERE IS A POTENTIAL FOR THE NON-CONFORMANCE RELATING TO THE BOOM COVER NOT BEING IN PLACE TO POSE A SEVERE/SERIOUS HEALTH RISK. THE SEVERITY IS NOT RELATED TO THE BOOM END CAP BEING LOOSE BECAUSE ONE SCREW WAS IN PLACE AND THIS ONE SCREW IS ABLE TO HOLD THE COMPONENT IN PLACE. THE SEVERITY INVOLVED WITH THIS INCIDENT HAS TO DO WITH THE FREE STANDING SCREW THAT WAS PLACED ON TOP OF THE BOOM ARM. THIS SCREW COULD POTENTIALLY FALL INTO THE STERILE FIELD AND CAUSE AN ADVERSE HEALTH EVENT. THIS IS NOT A SINGLE-USE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOOM END CAP WAS LOOSE AND ONLY ONE OF TWO SCREWS WAS HOLDING IT IN PLACE. THE SEVERITY IN THE EVENT IS NOT RELATED TO THE BOOM END CAP BEING LOOSE AS ONE SCREW IS ABLE TO HOLD THE COMPONENT IN PLACE. THE SEVERITY INVOLVED WITH THIS INCIDENT HAS TO DO WITH A FREE STANDING SCREW THAT WAS PLACED ON TOP OF THE BOOM ARM. THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SH 750MM 6GAS 8ELEC SHELVES BRY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA