BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DASH 3000

    MDR report key: 2122042 · Received May 24, 2011

    Report

    Report Number
    2124823-2011-00079
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 24, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K040458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMAGED CORD AND PLUG WERE RETURNED FOR EVAL. THE FAILURE WAS CAUSED BY DAMAGE TO THE ELECTRICAL CONTACT AREA INSIDE THE MOLDED POWER CORD PLUG END WHERE THE WIRE IS CRIMPED TO THE TERMINAL END OF THE METAL BLADE ASSEMBLY. THIS DAMAGE WAS LIKELY DUE TO YEARS OF HEAVY USE. FREQUENT CONNECTION AND DISCONNECTION INTO AND OUT OF THE AC OUTLET CAUSED STRESS ON THE BLADE THAT EVENTUALLY LED TO WEAKENING OF THE CRIMP-TO-WIRE CONNECTION. POTENTIAL CORROSION IN THE AC OUTLET MAY HAVE ALSO CONTRIBUTED TO THE EVENT CAUSED BY A HIGHER THAN NORMAL IMPEDANCE BETWEEN THE BLADE AND THE AC OUTLET INCREASING THE TEMPERATURE OF THE BLADE WHEN POWER FLOWS THROUGH THE CORD TO THE MONITOR. STANDARD INSTALLATION AND MAINTENANCE PROCEDURES RECOMMENDED BY GE HEALTHCARE REQUIRING INSPECTION, LEAKAGE CURRENT, AND GROUND CONTINUITY TESTING WOULD HAVE DETECTED FLAWS IN THE POWER CORD PRIOR TO USE. GE PROVIDES PREVENTATIVE MAINTENANCE LABELING FOR USERS TO INSPECT AND TEST THE INTEGRITY OF POWER CORDS IN THE "ELECTRICAL SAFETY CHECKS" SECTION OF THE DASH SERVICE MANUAL. THIS TESTING ASSURES THAT THE ELECTRICAL RESISTANCE OF THE SAFETY GROUND CONDUCTOR AND THE LEVEL OF LEAKAGE CURRENT (LINE CONDUCTOR-TO-GROUND AND NEUTRAL CONDUCTOR-TO-GROUND) MEETS THE IEC (B)(4) STANDARD. THE POWER CORD AND WALL OUTLET WERE REPLACED AT THE SITE AND THE MONITOR FUNCTIONED AS EXPECTED.

    Description of Event or Problem · 1

    A GE HEALTHCARE BIOMEDICAL ENGINEER LOCATED AT THE SITE REPORTED THAT A DASH 3000 UNIT HAD A CHARRED POWER CORD WITH A BURN POWER PRONG. A CLINICIAN NOTED A BURNING SMELL AND OBSERVED THE BURNING POWER CORD AND ELECTRICAL SOCKET. THERE WAS NO INJURY TO THE HOSPITAL STAFF AND THERE WAS NO PT ON THE MONITOR AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DASH 3000 PHYSIOLOGICAL PATIENT MONITOR MHX GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1