BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL ARM ARTICULATING EQUIPMENT BOOM

    MDR report key: 2480203 · Received February 28, 2012

    Report

    Report Number
    2031963-2012-00036
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    January 31, 2012
    Report Date
    January 31, 2012
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PATIENT INVOLVEMENT, THEREFORE, NO PATIENT DATA EXISTS. SERIAL NUMBER IS UNKNOWN. ADDITIONAL ATTEMPTS WILL BE MADE FOR THIS INFORMATION. THE DEVICE HAS NOT BEEN EVALUATED AT THE TIME OF THIS REPORT. EVALUATION SUMMARY: THE STRYKER EQUIPMENT DELIVERY SYSTEM (EDS) IS INTENDED FOR USE AS A CEILING-MOUNTED DEVICE FOR SUPPORTING OR POSITIONING EQUIPMENT IN THE SURGICAL SUITE AND/OR DELIVERS GASES OR ELECTRICITY TO THESE DEVICES. THE MMP-200 ARM-SET IS AN ARTICULATING ARM-SET THAT FEATURES A MOTOR UNDER THE HORIZONTAL ARM. THE MMP-200 OFFERS VERTICAL ARTICULATION IN CONJUNCTION WITH THE HORIZONTAL ARTICULATIONS POSSIBLE WITH THE OSC-400 AND OSC-600 ARM-SETS. THE CUSTOMER HAS NOT SCHEDULED AN ON-SITE EVALUATION OR REPAIR AT THE TIME OF THIS REPORT, THUS ROOT CAUSES OF THE POTENTIAL MALFUNCTIONS ARE UNKNOWN. HOWEVER, BASED ON THE INFORMATION KNOWN AT THIS POINT IN TIME, THERE IS NOT ENOUGH INFORMATION TO RULE OUT THE POTENTIAL HEALTH RISK OF THE BOOM DROPPING ENOUGH TO CAUSE THE EQUIPMENT TO FALL OFF THE SHELF. HOWEVER, IN THIS INSTANCE THERE WERE NO PATIENTS INVOLVED AND NO ADVERSE EVENTS WERE REPORTED. THIS NON-CONFORMANCE WILL BE MONITORED. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT WHEN TRYING TO ELEVATE THE LOWER ARM OF THE EQUIPMENT BOOM, IT DROPPED ABOUT 10 INCHES AND THEN CAUGHT ITSELF. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL ARM ARTICULATING EQUIPMENT BOOM BRY STRYKER COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1