BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCX MONITOR ARM

    MDR report key: 4935152 · Received June 15, 2015

    Report

    Report Number
    4935152
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 12, 2015
    Manufacturer
    GCX CORPORATION
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A MEDICAL TECHNICIAN THAT THE PHYSIOLOGICAL MONITOR TRAM ASSEMBLY FELL FROM THE SUPPORT ARM TO THE FLOOR AS A RESULT OF A FAILURE OF THE GCX MOLDED SWIVEL CUP ATTACHMENT.MANUFACTURER RESPONSE: THE PRODUCT WAS PURCHASED THROUGH GE WHO IN TURN PURCHASED IT FROM GCX. GE CAME TO THE HOSPITAL AND INSPECTED THE DEVICE AND THE TYPICAL ENVIRONMENTAL SETTING OF A DEVICE CURRENTLY IN USE IN ANOTHER PATIENT ROOM. THE DEVICE PART THAT FAILED WAS A COMPONENT OF A GCX SUB-ASSEMBLY. THIS IS APPROXIMATELY THE 3RD FAILURE OF THIS TYPE DEVICE IN LAST SEVERAL YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388742 GCX MONITOR ARM GCX MONITOR SUPPORT ARM MHX GCX CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NOT APPLICABLE.