BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPPORT ARM 177

    MDR report key: 1616559 · Received February 5, 2010

    Report

    Report Number
    8010042-2010-00011
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    January 6, 2010
    Report Date
    January 21, 2010
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    IOY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOGRAPHIC IMAGES OF THE REPORTED SUPPORT ARM HAVE BEEN RECEIVED AND EVALUATED. THE IMAGES SHOW THAT THE SUPPORT ARM BROKE AT THE JOINT NEAREST TO THE BRACKET. BASED ON PRIOR INVESTIGATIONS OF SIMILAR FAULTS OUR CONCLUSION INTO THIS MATTER IS THAT THE SUPPORT ARM HAS BEEN OVERLOADED, STRESSED TO FORCES EXCEEDING THE LIMITS STATED IN THE INSTALLATION INSTRUCTIONS. PRIOR PERFORMED INVESTIGATIONS HAVE LEAD TO A RE-DESIGN AND A CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARMS. THIS WAS IMPLEMENTED IN PRODUCTION DURING 05/2009. THE RETURNED SUPPORT ARM WAS MANUFACTURED DURING 2008. (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUPPORT ARM BROKE. (B) (4). (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPPORT ARM 177 IOY MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1