BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPNOSTAT MODULE

    MDR report key: 6915143 · Received October 5, 2017

    Report

    Report Number
    2124823-2017-00002
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 12, 2017
    Report Date
    December 1, 2017
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    MHX
    PMA / PMN Number
    K083750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION OF THE REPORTED ISSUE IS AS FOLLOWS: THE NAMED DEVICE WAS RETURNED FROM THE CUSTOMER SITE TO GE HEALTHCARE (GEHC) FOR FURTHER EVALUATION. GEHC ENGINEERING EVALUATION CONFIRMED THE MODULE HOUSING HAD A HOLE BURNED THROUGH IT AND WAS PARTIALLY MELTED. INTERNAL INSPECTION IDENTIFIED A PCB BOARD WAS DAMAGED WHERE THE BURN OCCURRED; ENGINEERING WAS NOT ABLE TO IDENTIFY THE EXACT LOCATION WHERE THE OVERHEATING STARTED DUE TO THE DAMAGE AND THERE ARE NO COMPONENTS MOUNTED IN THIS REGION OF THE PRINTED CIRCUIT BOARD ASSEMBLY THAT WOULD CAUSE THE OVERHEATING CONDITION. A BROKEN CONNECTOR WAS FOUND INDICATING THE DEVICE MAY HAVE BEEN DROPPED. A DEFINITIVE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED; POTENTIAL CAUSES COULD BE A HARDWARE FAILURE, CO2 SENSOR FAILURE, CONTAMINATION, OR CUSTOMER MISUSE (MISHANDLING). NO ADVERSE TREND WAS IDENTIFIED; THIS ISSUE WILL BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION OF THE ISSUE IS ON-GOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS NOT STARTING UP. VISUAL INSPECTION FOUND THE DEVICE TO HAVE A HOLE BURNED THROUGH THE CASING AND THE CASING WAS PARTIALLY MELTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695556 CAPNOSTAT MODULE MONITOR, PHYSIOLOGICAL, PATIENT MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1